Stryker
Senior Staff Regulatory Affairs Specialist (Remote)
This job is now closed
Job Description
- Req#: R519351
Employer Industry: Medical Devices
Why Consider this Job Opportunity:
- Salary up to $210,100.00 USD
- Bonus eligibility and benefits package
- Opportunities for career advancement and growth within the organization
- Remote work flexibility within the Pacific time zone
- Chance to be a core team member of the new product development team
- Collaborative work environment with internal and external stakeholders
What to Expect (Job Responsibilities):
- Lead the business unit in the development of processes/procedures for new or revised regulatory requirements
- Partner with various departments on project and product development teams
- Provide strategic direction to streamline department processes
- Serve as a regulatory affairs representative to improve awareness and communication on regulatory requirements
- Prepare complex submissions for approvals for clinical research, export, and commercial distribution
What is Required (Qualifications):
- Bachelor’s Degree (B.S. or B.A.) in Engineering, Science, or related discipline
- 7+ years’ experience in an FDA regulated environment
- 5+ years’ experience in medical device regulatory affairs
- RAC certification or Advance Degree (Master in Regulatory Affairs) strongly preferred
- Demonstrated applied knowledge of FDA and international medical device regulations/standards
How to Stand Out (Preferred Qualifications):
- Familiarity with EU MDR regulations
- Previous experience with biocompatibility requirements
- Knowledge of ISO 13485 and Quality System Regulation
- Experience with labeling requirements for medical devices
- Strong project management skills
#MedicalDevices #RegulatoryAffairs #RemoteWork #CareerGrowth #CompetitivePay
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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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