Regulatory Affairs Project Manager - Structural Heart
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁngersticks.
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
We are recruiting for a Regulatory Affairs Project Manager to join our team in Santa Clara, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide.
WHAT YOU’LL DO
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devices
- Assess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance
- Compile, prepare, review and submit Class III and Class II medical device submissions to regulatory agencies
- Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval
- Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action
- Utilize technical regulatory skills to propose strategies on complex issues
- Monitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teams
- Ensure compliance with product post marketing approval requirements
- Review product labeling and promotional material to ensure compliance with relevant regulatory requirements.
- Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members
- Provide regulatory support for internal and external audits
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s Degree in Medical, Science or Engineering related discipline OR an equivalent combination of education and experience
- 8+ years of experience in the medical device industry, including experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices
- Ability to work effectively on project teams.
- Must be able to juggle multiple and competing priorities.
- Strong written, verbal, presentation, and organizational skills.
- Scientific writing experience is required.
- Working knowledge of QSR, ISO, and EN standards.
- Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries.
- Advanced degree in Engineering, Sciences, or related discipline
- Previous experience with Class III IDE submissions and/or PMA submissions
- Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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