Senior Regulatory Affairs Specialist
Teleflex
full-time
Posted on:
Location Type: Office
Location: Ciudad de México • 🇲🇽 Mexico
Visit company websiteJob Level
Senior
About the role
- The Senior Regulatory Affairs Specialist will focus on the regulatory activities and deliverables.
- This role will be responsible for strategy and facilitating compliant execution of regulatory affairs activities.
- This role is responsible for effectively partnering with PM RA, Regional RA, Reg Ops and cross-functional teams.
Requirements
- Bachelor Degree in Science or Engineering disciplines.
- Minimum 5+ years of experience working within medical device industry.
- Knowledge and understanding of US, EU and Canada medical device regulations.
- Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required.
- Excellent technical writing experience within a medical device environment.
- Attention to detail and accuracy – essential.
- Fluent in English, both written and oral – essential.
Benefits
- Develop and execute comprehensive regulatory strategies for new and modified products.
- Conduct regulatory research and assessments.
- Collaborate with cross-functional teams, including Quality and Engineering.
- Interact and negotiate with regulatory authorities.
- Support and prepare for regulatory agency audits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsquality assurancerisk managementtechnical writingmedical device regulationsISO 1348521 CFR 820ISO 14971
Soft skills
attention to detailaccuracycommunication