Senior Regulatory Affairs Specialist

2 weeks ago

Reading, United Kingdom Page Group Full time

To combine knowledge of scientific, regulatory and business issues to enable product development, manufacture and life cycle maintenance to meet applicable regulatory requirements and applicable technical standards.

**Client Details**

My client is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

**Description**
- Lead RA representative for design change assessment projects for active medical devices (PEMS), responsible for assessing regulatory impact of the change - determining testing needs/ documentation needs/ registration needs. Close liaison with supply chain/regional regulatory folks etc. to ultimately implement the change in production.
- Lead and execute international product registrations attending to individual country specific requirements; monitor and report progress
- Participate to the review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements;
- Prepare and maintain regulatory files such as STED and MDD/MDR Technical Files;
- May participate in cross-functional product development teams as the regulatory representative; development of regulatory strategies
- May attend to audits performed by internal and external authorities to represent RA positions and processes;
- Assesses changes in regulations and helps to determine their impact;
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
- Handle CAPAs to implement corrective and preventive actions
- Drive regulatory affairs procedural updates, as needed, in collaboration with cross functional inputs.

**Profile**
- Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD/MDR CE Marking;
- Good working knowledge of Design Control, Software Life Cycle, Risk Management, V&V processes;
- Solid knowledge and material experience in international registrations/approval process for medical devices
- Degree or equivalent in engineering or scientific discipline, or equivalent proven experience.

**Job Offer**

Competitive package available

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