Manager, Regulatory Affairs - Abiomed, Inc.

Manager, Regulatory Affairs

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.

We are searching for the best talent for a Manager, Regulatory Affairs to support our Heart Recovery business. Remote work options may be considered on a case-by-case basis and if approved by the Company. Regardless of time zone, this role will work an EST schedule.

Purpose

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

Bachelors degree in engineering or science required, advanced degree is preferred. Minimum of 6+ years regulatory affairs experience (5+ w / advanced degree) in the medical device industry with a track record of successful FDA submissions required. Experience supporting embedded software & hardware device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304 / 82304 etc) required. History of successful IDE / PMA / 510(k) device submissions (Class III device submissions preferred) that include hardware and software components required. Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers. Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. Ability to effectively manage multiple projects and priorities. Strong communication and regulatory writing skills. Strong problem solving skills, interpersonal skills and effective team member. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. Ability to comprehend principles of engineering, physiology and medical device use strongly preferred. Class III cardiovascular device experience strongly preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Travel up to 10%. Must be able to effectively work remotely, based in a time zone with substantial EST overlap. 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.