by Ronald Barron | Jun 19, 2024 | Uncategorized
About the Role
Senior Regulatory Affairs Specialist – Acute Care & Monitoring
The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.
Location: There is a strong preference for candidates to be on-site in Boulder, CO. We will consider candidates to work remotely from the U.S.
Operating Unit
The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM. ACM is a $2B global business focused on airway management and patient monitoring technologies.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result – and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life
+ Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
+ Prepare FDA submissions and CE Mark Technical Files (MDD and MDR) for product changes and/or new products as required to ensure timely approvals for market released products.
+ Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval.
+ Prepare submissions and reports for FDA and support other international agencies as required by product status. May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
+ Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
+ Ensure personal understanding of all quality policy/system items that are personally applicable.
+ Follow all work/quality procedures to ensure quality system compliance and high-quality work.
+ Support post market regulatory compliance activities for US/EU product approvals.
+ Develop and maintain regulatory affairs department procedures and process improvements
+ Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
+ Assist in keeping company informed of regulatory requirements in the US and EU.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Other duties as assigned
**Must Have: Minimum Requirements**
+ Bachelor’s Degree with 4+ years of experience in regulatory affairs
OR
+ An advanced degree with 2+ years of experience in regulatory affairs
**Nice to Have**
+ 4+ years of medical device regulatory submission experience.
+ U.S. and EU regulatory submission experience (510k and EU MDR)
+ Experience with international standards (ISO, GHTF, ICH).
+ Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
+ Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
+ Experience working with cross-functional teams.
+ Experience working with technical documentation.
+ Project management skills.
+ Product development experience.
+ Knowledge of Medtronic procedures and systems.
+ Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
+ Strong oral and written communication skills.
+ Effective interpersonal skills.
+ Effective team member.
+ Ability to comprehend principles of engineering, physiology and medical device use.
+ Good analytical thinking skills.
+ Ability to effectively manage multiple projects and priorities.
+ Proficient skills with MS Word, MS Outlook, MS Excel.
+ Experience with Agile
APPLY HERE
by Ronald Barron | Jun 19, 2024 | Uncategorized
About the Role
Title: Director of Product Management, GDSN
Location: Remote- US
Job Description:
Here at Syndigo, we’re enabling our clients to deliver better eCommerce experiences. We’ve mastered the right data, right now. From creation to sale, that’s the value our partners get from us – a holistic, truly differentiated end-to-end solution that closes the loop while increasing sales.
Basically, we’re the accurate data behind how people feel when they shop online with confidence!
We cannot do all of this without our amazing people! Our employees make the magic happen here at Syndigo and we’re growing rapidly! We’re ready for you to collaborate with us to challenge the status quo!
The Director of Product Management at Syndigo will play a pivotal role in shaping the future of our product portfolio. This leadership position will be responsible for overseeing the entire product lifecycle, from ideation to execution, while collaborating closely with cross-functional teams to deliver world-class SaaS solutions. The ideal candidate will possess a strategic mindset, a deep understanding of market dynamics, and a proven track record of driving product innovation in a fast-paced environment. This leader will drive on our Syndication solutions, with a focus on our GDSN (Global Data Synchronization Network) capabilities, have background in global solutions, and lead a team of product owners.
HOW WE’LL BE WINNING TOGETHER DAY TO DAY
- Product Strategy and Roadmap: Develop and articulate a comprehensive product strategy aligned with the company’s vision and goals. Create and prioritize the product roadmap based on market trends, customer feedback, and competitive analysis.
- Team Leadership and Development: Lead and mentor a team of product managers, providing guidance, support, and coaching to foster professional growth and maximize team performance. Cultivate a culture of innovation, collaboration, and accountability within the product management organization.
- Market Research and Analysis: Conduct thorough market research to identify emerging trends, customer needs, and competitive landscapes. Translate insights into actionable strategies to drive product differentiation and market leadership.
- Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Engineering, Design, Marketing, Sales, and Customer Success, to ensure alignment and execution of product initiatives. Facilitate effective communication and coordination across departments to deliver high-quality products on time and within budget.
- Product Development and Execution: Oversee the entire product development lifecycle, from concept ideation to product launch and post-launch optimization. Define product requirements, manage project timelines, and ensure the successful delivery of product releases that meet or exceed customer expectations.
- Customer Engagement and Feedback: Act as the voice of the customer within the organization, gathering feedback, insights, and feature requests through various channels. Leverage customer feedback to inform product decisions and prioritize enhancements that drive customer satisfaction and retention.
- Performance Measurement and Optimization: Establish key performance indicators (KPIs) to track the success of product initiatives and measure their impact on business outcomes. Analyze performance metrics, iterate on product features, and continuously optimize product offerings to drive growth and market share.
WE SHOULD TALK IF THIS SOUNDS LIKE YOU
- Bachelor’s degree in Business, Engineering, Computer Science, or related field; MBA or advanced degree preferred.
- Proven experience (5+ years) in product management leadership roles, preferably within the SaaS industry.
- 2+ years of GDSN experience
- 1+ year of Leadership experience
- Strong strategic thinking and analytical skills, with the ability to translate market insights into actionable product strategies.
- Excellent leadership and communication skills, with the ability to inspire and influence cross-functional teams.
- Demonstrated track record of successfully launching and scaling innovative SaaS products in competitive markets.
- Deep understanding of product development methodologies, agile frameworks, and best practices.
- Passion for technology, innovation, and delivering exceptional customer experiences.
APPLY HERE
by Ronald Barron | Jun 19, 2024 | Uncategorized
About the Role
Title: Digital Marketing Manager
Location: United States
Job Description:
Splash’s mission is to develop the most innovative event technology on the planet to help marketers reach and engage their target audiences. From simplifying event asset creation to capturing attendee insights and measuring event impact, Splash enables marketers to efficiently scale event programs and connect event-driven engagement to business results. More than half of the Fortune 500 use Splash to streamline event marketing execution and optimize performance.
What we’re looking for
The Digital Marketing Manager will be responsible for developing, implementing, and managing marketing campaigns that promote Splash and its products/services to increase brand awareness and generate pipeline.
This role requires an in-depth understanding of digital marketing strategies, analytics, and tools, as well as the ability to collaborate with other departments to achieve business goals. Working closely with sales, customer success, product marketing, and marketing ops, to ensure our events are delivering the results needed to continue to fuel Splash’s growth.
In this role, you’ll get to…
Strategy Development
- Design and implement comprehensive digital marketing strategies, frameworks, and experiments leveraging intent-data, to increase brand awareness, drive traffic, and generate pipeline.
Integrated Campaign Management
- Plan and execute digital marketing campaigns across various channels including SEO/SEM, paid social (LinkedIn, Meta), display advertising (Google, 6Sense) and email.
- Identify and execute on optimization areas for digital ads (e.g. budget allocation/efficiency, conversion rate optimization, experimentation with new ad types, experimenting with messaging / audiences).
SEO and SEM
- Develop and implement SEO strategies to improve organic search rankings and drive website traffic in partnership with Content and Web teams.
- Surface relevant insights around organic search volume for specific keywords to ensure we’re incorporating this into our campaign and content planning process.
- Optimize key webpages for conversions.
- Manage paid search campaigns to drive efficient lead generation and pipeline.
Email Marketing
- Create and manage email marketing campaigns in partnership with Marketing Ops and Product Marketing, including newsletters, automated workflows, and lead nurturing sequences.
Performance Analysis
- Develop dashboards as needed, monitoring and analyzing campaign performance metrics, providing insights and recommendations to improve results.
- Use analytics tools such as Google, 6Sense, Salesforce, Tableau, Marketo and paid social platforms, and communicate performance metrics across Team Revenue.
Budget Management
- Manage the digital marketing budget, ensuring efficient allocation of resources and maximum ROI.
Collaboration
- Work closely with the sales team to ensure alignment of marketing and sales efforts. Collaborate with graphic designers, content creators, and other stakeholders to execute campaigns.
Stay Updated
- Keep ahead of the latest trends and changes in digital marketing (like AI), adjusting strategies as needed.
Qualifications:
Education
- Bachelor’s degree in Marketing, Business, Communications, or a related field, and/or relevant certifications (e.g., Google, 6Sense, Salesforce, Tableau) is a plus.
Experience
- Minimum of 5 years of experience in digital marketing, with a proven track record of managing successful campaigns and achieving results.
B2B Marketing (SaaS preferred)
Skills
- Strong understanding of current digital marketing concepts, strategies, and best practices.
- Proficiency in marketing automation and analytics tools (e.g., Google, SEMrush, 6Sense, Marketo, Salesforce, Tableau).
- Excellent written and verbal communication skills.
- Strong project management skills with the ability to manage multiple projects simultaneously.
- Analytical mindset with the ability to interpret data and make data-driven decisions.
- Creative thinking and problem-solving skills.
- Experience with A/B and multivariate experiments.
APPLY HERE
by Ronald Barron | Jun 19, 2024 | Uncategorized
About the Role
Title: Associate Experience Digital Designer
Details
- Department:Human Capital Management
- Schedule:Full Time/8-Hour Day Shift, Monday-Friday
- Location:Remote with about 20% travel
Benefits
- Paid time off (PTO)
- Various health insurance options & wellness plans
- Retirement benefits including employer match plans
- Long-term & short-term disability
- Employee assistance programs (EAP)
- Parental leave & adoption assistance
- Tuition reimbursement
- Ways to give back to your community
*Please note, benefits and benefits eligibility can vary by position, exclusions may apply for some roles (for example: Travel, PRN, Short-Term Option, etc.). Actual compensation offer will vary based upon role, education, experience, location, and qualifications. Connect with your Talent Advisor for additional specifics.
Responsibilities
The Associate Experience Digital Designer oversees mobile digital design for Ascension’s Human Capital Management (HCM) system. Responsible for the end-to-end design process to include research, design, experimentation, implementation, and optimization. Uses human-centered design methodologies to ensure positive, measurable user experience across all user roles and environments.
Responsibilities:
- Utilizes user research methodologies across broad stakeholder groups to inform design decisions
- Mocks up low or high fidelity wireframes / prototypes to test design options with users and communicate design decisions to key stakeholders
- Develops data collection methods and KPIs to effectively measure design ideas and monitor post-implementation experience
- Evaluates design effectiveness and drives for continuous improvement
- Develops and manages to project timelines
- Oversees the work of other designers engaged within the same body of work, including external contractors, to ensure consistency, quality and compliance with design standards and practices.
- Develops strategic innovations and bridges design with other disciplines.
- Mentors team members and takes on lead tasks such as coordinating meetings, following up on action items and managing work processes and quality control.
- Leads Community of Practice events and contributes to the deliverables and establishes methods to provide consistency, quality, and efficiency.
Requirements
Education:
- High School diploma equivalency with 3 years of cumulative experience OR Associate’s degree/Bachelor’s degree with 2 years of cumulative experience OR 7 years of applicable cumulative job specific experience required. 3 years of leadership or management experience preferred.
Additional Preferences
- Relevant experience includes human/user-centered design, user experience (UX)/user interface (UI), app or website development, managing product development teams
Key Attributes:
Excellent communication and interpersonal skills, influence, highly developed communication and collaboration skills, strong organizational skills, ability to thrive with multiple projects and aggressive timelines, strategic thinking, exceptional analytical skills, ability to manage cross-functional skills, innovative mindset, ability to prioritize tasks and delegate them appropriately, demonstrated ability to collaborate and create consensus, inclusive, expert in human-centered design, experience in user experience research, bridging the gap between technical feasibility and user desired features and design. Ability to lead a design team and manage multiple projects. Understanding of digital UX and global web platforms. Experience in Human Centered Design Systems thinking.
APPLY HERE
by Ronald Barron | Jun 19, 2024 | Uncategorized
About the Role
Title: Product Designer
Location: Massachusetts – Boston
Category: 704-R&D Comm PM
Job Description:
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We’re not just any public company – we made history in 2021 by becoming apublic benefit corporation(PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As aWork Anywherecompany, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us intransforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.
The Role
As a Product Designer at Veeva, you’ll play a key role in designing the future of our CRM product suite. We are looking for seasoned Product Designers who are excited to own their projects end-to-end.
You will serve a vital role here: from creating the vision for new features to crafting and finishing every detail in the product. We appreciate designers who think deeply, speak clearly, and love collaboration and feedback.
This is an incredible opportunity to design products that will impact millions of lives. Your work will be used by the largest global pharmaceutical and biotech companies to bring their medicine, treatments, and products to the doctors and patients who need them.
What You’ll Do
- Understand the business goals of Veeva CRM. Collaborate with Product Management and Engineering to identify the vision and requirements
- Solve user problems; define components and patterns
- Drive the design vision and strategy for your product area; collaborate with Design and Product Leadership.
- Execute at every stage of the design lifecycle
- Work cross-functionally with Product and Engineering partners to represent the design team and give feedback in planning and product channels
Requirements
- 3+ years of product design experience with mobile and web products
- Experience in an individual contributor role, on a Product Design team for desktop or mobile
- An outstanding portfolio, showcasing a foundation in Typography, Interaction, Visual Design, and Ideation
- You enjoy designing end-to-end experiences, including UX and Visual Design
- Experience working and collaborating with diverse teams in a dynamic, rapid-growth environment
- Experience partnering with Product Managers to develop the strategy and rationale for features
- Experience with prototyping to explore and convey design solutions
- A strong belief in user-centered design principles
- The ability to work independently to troubleshoot technical and process-related issues
- You’re a go-getter, self-sufficient, and seek out answers to your questions
- You’re quick, you work fast and you thrive in a high-pressure environment
- Amazing time management skills, with prior experience in a time-sensitive development environment
- Excellent written and verbal communication skills
- All applicants must have an online portfolio accompanying their resume/CV
Nice to Have
- Experience working with design systems
- Experience with Life Science or Sales & Marketing applications
APPLY HERE
