Senior Principal Regulatory Affairs Specialis

Introduction

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.

Overview

Position Summary:

 

This position is responsible for ensuring that pre‑market and/or post‑market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.

Responsibilities

Key Accountabilities

Essential Functions:

• Advise and direct teams on regulatory requirements related to new product development or significant changes
• Ensure test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s)
• Author regulatory plans as regulatory lead for new products or significant product changes, including interfacing with country market approval holders to confirm local regulatory requirements
• Act as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and international
• Review and approve labeling and marketing materials associated to regulatory filings
• Advise and direct teams on regulatory requirements for on-market product changes
• Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements
• Ensure company site and device registrations are compliant with applicable domestic and international regulations
• Review and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as required
• Increase working knowledge of regulations, standards, company SOPs and tools
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management
• Assist in tracking standards, regulations and all applicable requirements
• Other duties as assigned

Secondary Functions:

• Assesses regulatory gaps and take the appropriate corrective actions, as needed
• Supports internal and external audit as required
• Participates in regulatory improvement projects as required

Budget Managed (if applicable)

• N/A

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirements
• Ability to negotiate and influence others in establishing direction toward improved regulatory and enhanced compliance
• Ability to effectively communicate regulatory requirements to a broad population of constituents

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Ability to read and interpret domestic and international regulatory/quality standards related to our products
• Working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements
• De