We are currently looking for a Senior Regulatory Specialist with experience of Medical Device regulatory submissions to join a leading Global Biotechnology company. This position could be based either from their site in Warrington or in their site in Hampshire. Remote working may also be offered!
As the Senior Regulatory Specialist you will be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions and life cycle management activities while ensuring Regulatory Compliance is maintained for EMEA markets.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory Specialist will be varied however the key duties and responsibilities are as follows:
1. Compile, review and maintain regulatory submissions, Technical Files, and labelling as well as maintaining and updating dossiers for existing Marketing Authorizations.
2. Determine the information and documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
3. Contribute within new product development projects to ensure compliance with internal product commercialization process and global regulations.
4. Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits as well as support post-market surveillance and vigilance activities, including submitting reports to authorities.
To be successful in your application to this exciting opportunity as the Senior Regulatory Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline (e.g. Biology; Chemistry; Pharmacology etc.) in addition to strong working knowledge of In-Vitro Diagnostics and/or Medical Devices.
2. Proven industry experience in a Regulatory Affairs environment with experience of Regulations, Submissions and Technical Files as well as communication with Regulatory Authorities.
3. A working knowledge and practical experience with Clinical Trials for Medical Devices as well as regulatory audits, ISO certification, GMP requirements and documentation control.
Key Words: Regulatory Affairs | Regulatory Specialist | Medical Devices | In-Vitro Diagnostics | IVD | Technical Files | TF | TMF | EMEA | GMP | Brexit
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Georgia Walden
- Phone: 0203 910 2980
- Reference: J5631117
- Posted: 13th March 2019
- Expires: 10th April 2019