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Overview

Position Summary :

Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) / 46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA (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.

Responsibilities

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 (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) :

Internal Networking / Key Relationships :

Skills & Capabilities :

Qualifications

Minimum Knowledge & Experience Required for the Position :

International Mobility :

Travel requirements :

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 for assistance.

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