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Director, Regulatory Affairs

Company: Haemonetics Software Solutions
Location: Boston
Posted on: February 25, 2021

Job Description:

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 required
    • 10+ years experience with direct regulatory agency interactions required
    • 5+ years experience in Pharmaceutical Regulatory Affairs preferred
    • 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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