Regulatory Affairs Specialist

2 days ago


StokeonTrent, United Kingdom Harris Lord Recruitment Full time

The opportunity to work within a well-established and pioneering provider of medical device products. You will work within a close-knit and collaborative team within a growing company with great progression potential.
Working within the regulatory affairs team, this fast-paced opportunity gives you the chance to be a part of a growing business and to make a genuine contribution to their future.

This specialist job role could suit a regulatory affairs professional looking to make a difference within the company and act as a mentor to junior regulatory staff members.
The position:
The key focus of this role is to support regulatory obligations of the organisation and its products throughout the full product lifecycle. Preparation and submission of documents for registering and maintaining the Company’s site and global product registrationsin accordance with specified country requirements. Coordinating information systems to track registration status and renewal dates for products and regulatory documents. There will also be the responsibility to liaise with regulatory authorities and notifiedbodies as required and generally support the Regulatory Affairs Manager in the delegation of activities.

**Experience**:

- 3-5 years in a similar role within Medical Devices or Pharma industry.
- Understanding of regional regulatory requirements (EU & US)
- Previous knowledge of regulatory affairs
- Strong organisational skills
- Ability to accurately follow written instructions
- Proficient with Microsoft Office packages
- Brilliant communication skills and enthusiasm towards work
- Must be willing to work in office Monday-Friday 9am-5pm

Key Words:
Regulatory affairs, RA, documentation, physical testing, test, inspection, protocols, procedures, ISO 13485, medical device, meddev, medical technology, audit, SOP, graduate, entry level, junior, trainee, training, progression,pharmaceutical, drug, submission,artwork, MAA, authorisation, approval.

Harris Lord is working as a Recruitment Agency in relation to this position.



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