Regulatory Affairs Specialist Hybrid
Regulatory Affairs Specialist Hybrid
Posted on :
08-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid or Onsite
Stryker is hiring a Regulatory Affairs Specialist. This position is Hybrid/Onsite supporting our Endoscopy Division in Tempe Arizona.
What you will do
As a Regulatory Affairs Specialist you will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA Notified Bodies and other regulatory bodies.
- Identifies information sources and resources for local regional and global regulations
- Collects organizes and maintains files on local regional and global regulatory intelligence and other related information
- Monitors the regulatory environment (specific regulations guidance and other relevant information by product types geography etc.
- Provides information used to evaluate proposed products for regulatory classification and jurisdiction
- Research requirements (local national international) applicable guidance and standards and options for regulatory submissions approval pathways and compliance activities
- Assists in the development of regulatory procedures and SOPs
- Collects and organizes information on requirements for regulatory quality preclinical and clinical data to meet applicable regulations
- Organizes materials from preclinical and clinical studies for review and assists in the review process
- Compiles and organizes materials for presubmission reports and communications
- Assists in the preparation of dossiers and presubmission and submission packages for regulatory agencies
- Tracks the status of applications under regulatory review and provides updates to the regulatory team
- Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
- Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
What you need
- Bachelors degree in engineering or science or related
- 0 2 years related work experience in an FDA or regulated industry required
Preferred
- 1 years medical device or regulatory experience
- Knowledge of FDA and international medical device regulations and standards (CFR MDR QSR ISO 13485 MDSAP etc.
- Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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