Manager, Regulatory Affairs - Abiomed, Inc.

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 pre-submission and during the review period. Your core focus will be regulatory leadership for software (both SiMD and SaMD) and hardware development and changes. Through your engagement in this role, you will help shape the life-saving field of heart recovery.

The ideal candidate will:

• Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions that include software and hardware components

• Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art 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

Key Responsibilities:

• Independently support cross-functional new product development projects with a specific focus on software (both SiMD and SaMD) and hardware aspects, and lead compilation of all materials required for submissions to FDA.

• 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.

Qualifications

Minimum Qualifications:

• Minimum of a Bachelor's Degree required, Advanced Degree strongly preferred; Science or Engineering discipline highly desired.

• Minimum of 6+ years relevant Regulatory Affairs experience required (5+ with Advanced Degree).

• Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions required.

• History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components.

• Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers.

• Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc).

• 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.

• Class III cardiovascular device experience strong 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.

The base pay range for this position is $118,000 to $185,000 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.