Senior Manager, Regulatory Affairs 5/21/2019
JOB DESCRIPTIONAPPLY Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed s 1,400 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
ABIOMED, maker of Impella, has the immediate opportunity for a senior-level Regulatory Affairs professional to join its growing, dynamic team. In this important and exciting role, the Senior Manager of Regulatory Affairs will be responsible for leading and executing US regulatory plans for our Impella product lines. Reporting directly to the head of our Global Regulatory Affairs, this person will partner closely with the Product Development, Clinical Affairs, the Medical Office, Marketing, and Production departments to define and implement regulatory programs. If you are a Regulatory Affairs professional who considers yourself a life-long learner, you appreciate variety in your contributions and Outstanding colleagues, this could be the perfect opportunity for you! Through your leadership in this role, you will help shape the life-saving field of Heart recovery!
As a Senior Regulatory Affairs Manager with ABIOMED you will:
* Act as a leader for the team someone who is positive, forward-looking, accountable, action-oriented, and focused on delivering results
* Provide key 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
* 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
* 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
* 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
* Manage and mentor junior Regulatory Affairs staff members to become self-sufficient in efficiently completing their RA tasks
* Communicate regulatory strategies and project status to internal stakeholders
* Interact with and influence external regulatory agencies and trade associations
Education & experience required:
* Advanced degree in Engineering or Science (PhD preferred)
* 10+ years of Regulatory Affairs experience
* 3+ years of Regulatory Affairs experience (technical, scientific & clinical) with a cardiovascular device company
* Demonstrated clinical background with an understanding of cardiovascular disease and heart failure
To be successful in this role, one must have:
* Passion for putting patients first and for working as part of an incredible team!
* Ability to effectively communicates ideas and information clearly (oral and written) to peers, senior staff, and more broadly to internal and external stakeholders
* Exceptional technical writing abilities
* Strong project management and leadership skills
* Experience effectively working with cross-functional teams and building strong relationships across departments
* Ability to act independently to determine methods and procedures, while effectively collaborating within a team environment
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.