Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

Patients First | Innovation | Winning Culture | Heart Recovery

The Senior Manager, Regulatory Affairs is an individual contributor, subject-matter expert role that will be responsible for leading and executing US regulatory plans for our Impella product lines. This position reports to the head of our Global Regulatory Affairs and will partner closely with Product Development, Clinical Affairs, the Medical Office, Marketing, and Production departments as you define and implement regulatory programs. Through your leadership in this role, you will help shape the life-saving field of heart recovery.

KEY RESPONSIBILITIES:

* Provide leadership to develop and implement regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives
* Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities
* Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, PMA Amendments, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and periodic study reports as assigned
* Actively engage as Regulatory Affairs representative on project teams
* Serve as a key liaison with the FDA by conducting presentations to and negotiations with agency reviewers as needed
* Strategize and develop regulatory plans and documents for new products, product updates, manufacturing process changes, marketing materials, and clinical trials
* Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
* Review and approve all changes to manufacturing processes and products to ensure compliance with Regulatory Affairs and QSR guidelines
* Ensure that Regulatory Affairs requirements are fully understood, implemented and/or mitigated in new product, clinical, marketing, and other business processes
* Individual contributor that mentors junior Regulatory Affairs staff members to become self-sufficient in efficiently completing their RA tasks
* Be a leader- positive, forward looking, accountable, action-oriented, delivering results
* Communicate regulatory strategies and project status to internal stakeholders
* Interact with and influence external regulatory agencies and trade associations

QUALIFICATIONS:

* Advanced degree in engineering or science required, PhD preferred
* Technical, scientific and clinical experience with cardiovascular devices preferred
* 7 years of Regulatory Affairs experience with a cardiovascular device company preferred
* Solid experience and proven track record in successful FDA (PMA, 510k, IDE) submissions
* Demonstrated clinical background and understanding in cardiovascular disease and heart failure
* Strong project management and leadership skills
* Prior experience in working with cross-functional teams and building strong relationships across departments
* Effectively communicates ideas and information clearly (oral and written) to peers, senior staff, and more broadly to internal and external stakeholders
* Ability to act independently to determine methods and procedures, while effectively collaborating within a team environment

Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.Abiomed maintains a drug-free workplace.