Regulatory Affairs Specialist
Teleflex
full-time
Posted on:
Location Type: Office
Location: Kamunting • 🇲🇾 Malaysia
Visit company websiteJob Level
JuniorMid-Level
About the role
- Overseeing preparation of product registration documents and product tender applications
- Review and evaluate technical and scientific data and reports
- Review and evaluate change impact on US 510(k), license in Health Canada
- Review transfer product project impact on 510(k), license in Health Canada
- Review and approve product labelling to ensure compliance
- Apply for new Health Canada license and amend existing licenses
- Maintenance of updated and revised standards to support compliance
- Participate in R&D projects, changes to existing products and processes
- Update and maintain regulatory database
- Review and approve marketing pieces i.e. brochures
- Review and approval of validation protocols/reports and change requests
- Comply with requirements of Occupational Safety and Health Act 1994
Requirements
- Bachelor’s Degree in Engineering or equivalent
- Minimum 2 years Quality System or Regulatory experience in medical device industry
Benefits
- Teleflex is an equal opportunities employer
- Comprehensive hiring process
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
product registrationproduct tender applicationstechnical data evaluationscientific data evaluationregulatory database maintenancevalidation protocolschange requestscompliance standardsHealth Canada licensing510(k) submissions
Soft skills
attention to detailanalytical skillscommunication skillsorganizational skillscollaborationproblem-solving
Certifications
Bachelor’s Degree in Engineering