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Regulatory Affairs Sr Specialist

4 months ago

Montreal, Canada Zimmer Biomet Full time
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.

What You Can Expect

This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

How You'll Create Impact

Assist with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions

Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates

Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Evaluates risk of proposed regulatory strategies and offers solutions

Reviews proposed labeling for compliance with applicable US and international regulations

Writes, manages, and approves the development of package inserts

Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations

Reviews proposed product changes for impact on regulatory status of the product

Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams

Follows Zimmer Biomet regulatory affairs policy and procedures

May provide training and/or guidance to entry-level associates, analysts, interns, and specialists

Communicates with regulatory and governmental agencies

Miscellaneous responsibilities as assigned

What Makes You Stand Out

Demonstrated strong writing and communication skills.

Strong interpersonal skills and attention to detail.

Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities.

Proficient knowledge of overall business environment, the orthopaedic industry, and the marketplace-Mastery of relevant regulations pertinent to medical devices, biologics, drugs, and combination products as applicable

Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization

Able to identify risk in regulatory strategies

Robust product knowledge

Advanced anatomic knowledge-Proven analytical and negotiation skills

Experience with solving problems and concerns-Intermediate computer skills, including Microsoft Office Suite-Ability to lead a team and influence others-Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU

Your Background

Bachelor's Degree (non-CAN or non-US equivalent) required. Technical/engineering degree, life sciences, or related field preferred. Alternate degrees may be considered.

Advanced degree preferred

A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required

A minimum of 2 years of experience in orthopaedic or medical device industry preferred

Regulatory Affairs Certification ( CAN, US or EU) preferred

A combination of education, experience, leadership, strategy, and RA influence may be considered

Travel Expectations

Up to 15%

EOE/M/F/Vet/Disability