Principal Regulatory Affairs Specialist

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.

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.

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.

• N/A

• To be determined based on department needs.

• Effective verbal communication in individual and group settings
• Strong writing skills for submission preparation
• Detail oriented with good organizational skills and able to meet deadlines
• Ability to prioritize while balancing multiple projects, with strong planning skills
• Effective decision maker

Minimum Knowledge & Experience Required for the Position:

• Requires a Bachelor degree, preferably in regulatory or science related areas
• Minimum of 8-years’ regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
• Experience in the preparation of regulatory submissions to US FDA, Health Canada and/or EU Notified Body with in the past 8 years.
• Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulatory, MDSAP Companion Document, with some exposure to either EU MDR or EU IVDR
• Effective verbal and written communication in individual and group settings
• Ability to prioritize and balance work load, with minimal supervision and in a fast pace environment
• Language fluency: English essential

• Required: No

• 5-10% of time per year, domestic and international

The annual base salary range for this role is currently $150,000 to $180,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com