We are seeking a Regulatory Affairs Specialist II. This individual will assist and coordinate the compiling, preparation and assembly of regulatory submissions and support files for medical devices to be submitted to the FDA and EU regulatory bodies.
- Assist in the identification of relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements
- Assist in the preparation and maintenance of product registrations and renewal of Technical Files and communication with corresponding Agents, US FDA 510(k) Premarket Notifications and Technical Files for EU and EU AR
- B.S. or B.A. preferred.
- Two to Three years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry.
- GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, MDR 2017/745, ISO harmonized standards (EN14971, EN 13408, EN 13824).
- Quality control methodology, QA controls systems and production methodologies.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.