Senior Regulatory Affairs Specialist

Key Areas of Responsibility:

•  Evaluates the regulatory environment and provides internal advice for proposed device changes to ensure product compliance

• Supports a broad portfolio of orthopaedic implants and instruments across Stryker global manufacturing sites

• Evaluates proposed design and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Collaborates with project teams, provides technical guidance and advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

• Monitors the progress of the regulatory authority review process through appropriate communications with the authorities

Education / Work Experience:

• BS in Engineering, Science, or related or MS in Regulatory Science
• 2+ yrs experience
• RAC(s) preferred

Knowledge / Competencies:

• General understanding of product development process and design control.

• Understanding of FDA, Europe and international medical device regulations required.

• Previous experience with Class II/III medical devices preferred.

• Previous experience drafting 510(k)s and EU submissions preferred.

• Experience interacting with regulatory agencies preferred.

• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

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