Regulatory Affairs Specialist - Lower Extremities/Biologics
Regulatory Affairs Specialist - Lower Extremities/Biologics
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Regulatory Affairs Specialist Lower Extremities/Biologics
Memphis TN
Stryker is looking for a Regulatory Affairs Specialist to join our Trauma & Extremities Biologics team. In this role you will help bring innovative soft tissue and biologic medical technologies to market while ensuring compliance with global regulatory requirements. You will work independently and cross-functionally to drive strategic regulatory initiatives prepare submissions and interact with regulatory agencies and internal partners.
Work Flexibility: Hybrid
Candidates must reside within a commutable distance to Memphis TN and be available to work onsite two days per week.
What Youll Do
- Prepare regulatory submissions and pre-submission materials for global health authorities
- Research global regulatory requirements standards and approval pathways to support product development and compliance
- Support development and maintenance of regulatory policies procedures and SOPs
- Collect and organize information from quality clinical and preclinical teams for submissions
- Coordinate documentation and data for internal reviews and regulatory filings
- Support meeting preparation and communications with internal stakeholders and regulatory bodies
What you need
Basic Qualifications:
- Bachelors degree in Engineering Science or a related field
- 0 years of experience
Preferred Qualifications:
- Experience in Regulatory Affairs
- Familiarity with medical device regulations and FDA requirements
Required Experience:
Unclear Seniority
Employment Type
Full-Time
