Senior Regulatory Affairs Specialist
Teleflex
full-time
Posted on:
Location Type: Office
Location: Morrisville • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Develop US, EU, and Canada strategies, assessments and submissions for complex projects.
- Conduct research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments.
- Assume responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments.
- Communicate with Commercial RA to ensure timely notification of changes.
- Work with internal groups to investigate and recommend solutions for regulatory issues.
- Interact and negotiate with regulatory authorities during the development and submission review.
- Support regulatory agency and/or notified body audits as needed.
- Participate in development and approval of risk activities and other deliverables.
Requirements
- Bachelor’s degree in a science or engineering field, or equivalent work experience.
- 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of experience with Class I, II or III medical devices.
- Proven history of successful domestic and/or international submissions.
- Strong analytical and critical thinking skills.
- Strong verbal and writing communication skills.
- Ability to manage and prioritize multiple projects to meet deadlines that align with the BU’s objectives.
- Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.
- Proficiency in MS Office software programs.
- RAC certification is a plus.
Benefits
- Up to 10% travel 📊 Resume Score Upload your resume to see if it passes auto-rejection tools used by recruiters Check Resume Score
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory assessments510(k) submissionsEU MDD Technical FileMDR Technical DocumentationCanadian license submissionrisk activitiesmedical device submissionsanalytical skillscritical thinking
Soft skills
verbal communicationwriting communicationproject managementprioritizationteam collaborationproblem-solving
Certifications
RAC certification