Senior Regulatory Affairs Specialist - Abiomed, Inc.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Abiomed business. This role will work a Flex/Hybrid schedule and be based in the Danvers, MA office.  There is NO remote option and relocation assistance is not provided.

Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Abiomed. The individual combines knowledge of scientific, regulatory and business issues to ensure that products, which are developed, manufactured or distributed by J&J MedTech Heart Recovery meet the required legislation in Canada, Latin America and United States. Through your engagement in this role, you will help shape the life-saving field of heart recovery.

You will be responsible for:

• Prepare and submit regulatory documents, including applications for product registrations, amendments, annual renewals, and post-market surveillance reports, to respective health authorities (e.g. US FDA, Health Canada).
• Collaborate with regional regulatory partners as needed in preparing submissions for global expansion.
• Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments.
• Maintenance of licenses throughout product lifecycle.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions .
• Provide regulatory support for internal and external audits (e.g. MDSAP).
• Monitor and anticipate changes in regulations in responsible jurisdictions.
• Prepare regulatory documents (e.g. CFG) to support global expansions or tenders.
• Have Regulatory Affairs experience in the medical device industry with a track record of successful Canada, LATAM or US FDA submissions supporting commercial medical devices.
• Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art Class II and class III cardiovascular medical devices.
• Be energized by joining a world-class company and regulatory team.
• Enjoy teamwork and thrive as a member of dynamic cross-functional teams.
• Build and maintain strong interpersonal relationships within and outside of the company.
• Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results.
• Be adaptable and thrive in a dynamic work environment where variety is the routine.
• Embrace change, continuous learning, and work skills improvement.
• Able to manage multiple competing priorities.

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree required, Advanced degree is strongly preferred. Science or Engineering discipline highly desired.
• At least of 2+ years of related professional Regulatory Affairs experience required (1+ with Advanced Degree).
• Experience in reviews of engineering, manufacturing, marketing, labeling a