Principal Specialist, Regulatory Affairs
West Pharmaceutical Services
full-time
Posted on:
Location Type: Hybrid
Location: Exton • Pennsylvania • United States
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Job Level
About the role
- Develop and implement medical device regulatory strategies for administration and safety systems
- Author and review complex product submissions guidance and negotiate submission issues with Agency personnel
- Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams
- Prepare US, EU, and other international submissions for new products and product changes
- Work with RA team to build Regulatory strategies for medical device development platform
- Provide leadership to product development teams for regulatory issues and questions
- Provide support to market-released products as necessary
Requirements
- Bachelor's Degree science, math, engineering, life sciences or related discipline required
- Minimum 8 years related work experience required
- Medical device or Combination Product regulatory experience preferred
- Excellent oral communication and technical writing skills
- Advanced knowledge of product life cycle, product development, design control and change control
- International regulatory competency
- Experience with administration and safety systems preferred
- Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745)
- History of successful US 510(k) device and EU technical documentation submissions
- Experience directly interacting with government agencies
- Strong negotiation and decision-making skills
Benefits
- Generous Paid Time Off (PTO)
- Global Career Opportunities
- Inclusive & Collaborative Culture
- Recognition & Rewards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesproduct submissionsmedical device developmentproduct life cycledesign controlchange controlUS Class I device experienceEU Class IIa device experienceUS FDA regulationsEU MDD and MDR
Soft Skills
oral communicationtechnical writingleadershipnegotiationdecision-making
Certifications
Bachelor's Degree