Manager, Regulatory Affairs - Abiomed, Inc.

Manager, Regulatory Affairs

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.

The Regulatory Affairs Manager will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA both pre-submission and during the review period. Your core focus will be regulatory leadership of a new product platform under investigational use, providing both clinical and technical regulatory leadership and as well as supporting software (both SiMD and SaMD) and new capital equipment development. Through your engagement in this role, you will help shape the life-saving field of heart recovery.

You will be responsible for :

• Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions supporting investigational and 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.
• Independently support cross-functional new product development and sustaining projects, and lead compilation of all materials required for submissions to FDA.
• Independently support clinical programs including investigational device studies, post-approval studies, and registries designed to support marketing applications.
• Provide regulatory leadership of clinically focused FDA submissions including panel track PMA supplements.
• Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
• Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance.
• Provide support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings.
• Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions.
• Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies.
• Assist in the maintenance and improvement of regulatory SOPs.
• Interact and negotiate with regulatory agencies on defined matters as needed.
• Provide mentorship to junior-level team members.

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 via https : / / www.jnj.com / contact-us / careers . Internal employees contact AskGS to be directed to your accommodation resource.

The base pay range for this position is $115,000 to $197,800. 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.