Senior Principal Regulatory Affairs Specialist

Senior Principal Regulatory Affairs Specialist

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary: Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k) s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.

Key Accountabilities

Essential Functions:

• Participates as a regulatory design team member for new and significant changes to IL-labeled product, providing early input on analytical and clinical test requirements, acceptance criteria and regulatory submission strategy.
• Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan.
• Performs labeling reviews and Change Order (CO) reviews/signatures for new product and significant product modifications.
• Prepares FDA 510(k), Health Canada license and EU Notified Body submissions for new products and significant modifications, coordinating deliverables with R&D and Marketing, authoring summary analytical and clinical reports, interfacing with Regulatory agency/Notified Body and advising on strategies and requirements throughout the registration process.
• Reviews and approves commercial materials for compliance/consistency with registrations, including by not limited to brochures, presentations and training materials.
• Other regulatory activities as needed to support new product launches and significant product modifications.

Key Accountabilities

Essential Functions:

• Participates as the regulatory design team member for new and significant changes to IL-labeled product, providing early input on analytical and clinical test requirements, acceptance criteria and regulatory submission strategy.
• Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan.
• Performs labeling reviews and Change Order (CO) reviews/signatures for new product and significant product modifications.
• Prepares FDA 510(k), Health Canada license and EU Notified Body submissions for new products and significant modifications, coordinating deliverables with R&D and Marketing, authoring summary analytical and clinical reports, interfacing with Regulatory agency/Notified Body and advising on strategies and requirements throughout the registration process.
• Reviews and approves commercial materials for compliance/consistency with registrations, including by not limited to brochures, presentations and training materials.
• Other regulatory activities as needed to support new product launches and significant product modifications.

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on…