Regulatory Affairs Specialist - Essex - 12 Month Contract

REGULATORY AFFAIRS SPECIALIST - SOUTHEND - 12 MONTH CONTRACT

Optimus Search is currently in partnership with a leading Medical Device company in the UK looking to recruit an experience Regulatory specialist at their site in Essex. This will be an initial 12 month contract.

The Regulatory Affairs (RA) Specialist is responsible for providing technical support to regulatory affairs management to ensure continuous compliance with domestic and international regulatory requirements. The RA Specialist will be responsible for supporting global product registrations, submissions, and licensing and coordinating import/export activities.

MAIN RESPONSIBILITIES:

- Write, prepare, and manage regulatory submissions and filings (ie 510(k), CE Marking, HC Medical Licensing).
- Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
- Act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support.
- Participate in inspections/audits by the notified body or other international regulatory agencies by producing requested documents or answering any inquiries for information.
- Assist in the development of regulatory best practices, processes and procedures.
- Perform other duties as required.

KEY REQUIREMENTS:

- BA or BS, preferably in a science discipline (ie Biology or Chemistry)
- Minimum of 5 years' experience in the medical device regulatory affairs discipline: knowledge of domestic and international medical device/regulation (ie Class I and II devices), practical experience in global registrations and filings (ie US, EU, Canada), and import and Export compliance
- Demonstrate strong attention to detail and solid interpersonal skills including the ability to work with teams and handle multiple ongoing projects.
- Great verbal and written communication skills, working knowledge of MS Word, Excel, and other MS Suite applications.
- Current knowledge of FDA 21 CFR Part 820, MDD Directive, and ISO standards.

If interested please respond with an updated C.V.