Regulatory Affairs Specialist
Skills
21 CFRCFRDocumentationMedical DevicesTechnical DocumentationVerification And ValidationeSTAR
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree in Engineering Life Sciences Regulatory Affairs Legal or related field
- 5–10+ years of global medical device regulatory experience
- Proven end-to-end FDA 510(k) submission experience
- Strong knowledge of FDA 21 CFR Parts 807 and 820 FDA guidance eSTAR EU MDR 2017/745 Annex II/III technical documentation and Canadian medical device regulations
- Experience with ophthalmic devices capital equipment diagnostic devices software in medical devices and or cybersecurity
Nice to have
- Strong technical writer
- Highly organized
- Detail-oriented
- Independent
- Fast-paced environment
Day to day
- Author and compile a complete FDA 510(k) submission in eSTAR format.
- Review technical files across design controls V&V risk labeling clinical evidence software and cybersecurity as applicable.
- Perform regulatory gap assessments and support FDA EU MDR and Health Canada submission readiness across global markets.