Stryker
Principal Regulatory Affairs Specialist (Remote)
This job is now closed
Job Description
- Req#: R525024
Employer Industry: Medical Devices
Why consider this job opportunity:
- Salary up to $210,100.00 USD plus bonus eligible + benefits
- Opportunity for career advancement and growth within the organization
- Flexibility to work remotely
- Collaborative and dynamic work environment
- Involvement in innovative product development impacting patient care
What to Expect (Job Responsibilities):
- Advise project teams on compliance with global regulatory requirements and lead the development of regulatory processes
- Collaborate with cross-functional teams, including marketing, engineering, and clinical, to streamline product development
- Prepare complex regulatory submissions for clinical research and commercial distribution
- Mentor team members and facilitate training programs on regulatory compliance
- Monitor regulatory changes and communicate impacts to stakeholders
What is Required (Qualifications):
- Bachelor’s Degree (B.S. or B.A.) required, preferably in Engineering, Science, or a related discipline
- 7+ years of experience in an FDA regulated environment required
- 5+ years of experience in medical device regulatory affairs required
- Demonstrated applied knowledge of FDA and international medical device regulations/standards
- RAC certification or Advanced Degree (Master in Regulatory Affairs) strongly preferred
How to Stand Out (Preferred Qualifications):
- Experience with biocompatibility requirements and Quality System Regulation
- Strong understanding of ISO 13485 and Medical Device Directive
- Previous involvement with global regulatory submissions and approvals
- Familiarity with project management tools and methodologies
- Proven ability to analyze and improve regulatory processes
#MedicalDevices #RegulatoryAffairs #RemoteWork #CareerGrowth #InnovativeEnvironment
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.
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