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.
* 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 field, or MS in Regulatory Science.
* 2+ years of 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.