Director, Regulatory Affairs
Company: Haemonetics Software Solutions
Posted on: February 25, 2021
Haemonetics is committed to the protection of personal data in
accordance with applicable laws and regulations.-- The editor and
data controller ofwww.haemonetics.com is Haemonetics Corporation,
400 Wood Road, Braintree, Massachusetts, 02184 U.S.A. The global
Data Privacy Officer of Haemonetics can be reached at this address.
We are constantly looking to add to our core talent. If you are
seeking a career that is challenging and rewarding, a work
environment that is diverse and dynamic, look no further -
Haemonetics is your employer of choice. This role works with the
Plasma and Blood Center Business Unit teams to design innovative
pathways to broaden current promotional claims and gain regulatory
approval of new Haemonetics products. Oversees the development of
documentation to support: 510(k) premarket notifications,
Investigational Device Exemptions (IDEs), NDA/ANDA Prior Approval
Supplements (PAS), Canadian Medical Device License applications,
Canadian Drug License applications, CE Technical Files, and other
global registrations. Supervises the regulatory affairs group to
ensure compliance with global regulations. Responsibilities :
- Develop and maintain strategic partnerships with Business Unit
teams to achieve global growth objectives.
- Create collaborative working relationships with US FDA, Health
Canada, and other global regulatory bodies.
- Create a robust regulatory strategy that guides product
development and launch throughout the product life cycle.
- Supervise the development and submission of documents for US
FDA, Health Canada, and other regulatory bodies, including
responding to questions from regulatory agencies.
- Help create clear, concise, accurate regulatory filings that
receive swift review and approval by regulators with a minimum of
questions through effective collaboration with Marketing,
Development, Operations, Clinical, and Quality Assurance.
- Initiate, drive, and actively participate in cross-functional
initiatives to drive global growth, sustain positive compliance
profile, and support growing complex product portfolio.
- Actively participate in FDA, Notified Body, and other
regulatory agency inspections and audits.
- Monitor evolving regulations and proactively plan for and
execute resulting changes.
- Develop regulatory team members and organizational structure to
continually support evolving needs of the business.
- Act as the SME (Subject Matter Expert) for the regulatory team,
providing training and guidance as required. Qualifications:
- Bachelor's Degree in Biology or Medical Sciences required;
advanced degree preferred
- 10+ years experience in Medical Device Regulatory Affairs
- 10+ years experience with direct regulatory agency interactions
- 5+ years experience in Pharmaceutical Regulatory Affairs
- Strong leadership skills and communication skills Throughout
our history, we have earned a solid reputation for product
innovation, technical expertise, and operational excellence. Today,
our products, internal research and development, marketing
partnerships, and product acquisitions reflect our unwavering
commitment to provide safe and available blood for patient
transfusions and for use in pharmaceuticals.We rely on our talented
global workforce to help us achieve our mission of providing
innovative medical devices that advance the safety, quality, and
availability of the world's blood supply. To achieve our business
goals and objectives, we are committed to attracting and retaining
the best and brightest talent while offering a challenging,
dynamic, and exciting work environment that offers professional
growth and development.
Keywords: Haemonetics Software Solutions, Boston , Director, Regulatory Affairs, Executive , Boston, Massachusetts
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