Senior Regulatory Affairs Specialist - Abiomed, Inc.

Senior Regulatory Affairs Specialist

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.

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.

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 :

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us.

The anticipated base pay range for this position is $89,000 to $143,750. Additional Description for Pay Transparency : Subject to the terms of their respective plans, employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits : Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth / adoption / foster care of a child Condolence Leave 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below.