Work Flexibility: Hybrid

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 Science2+ yrs experienceRAC(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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Travel Percentage: None