Senior Regulatory Affairs Associate

6 days ago

New Works, United Kingdom CK GROUP Full time

CK Group are recruiting for a to join a Senior Regulatory Affairs Associate global healthcare provider to hospitals, clinics and homes, based remotely on a contract basis for 12 months.
**Hourly rate**:
£73.16
**The Company**:
Our client is one of the worlds leading healthcare providers and has been highly innovative in providing healthcare solutions to unmet medical needs through scientific advancement as well as strategic acquisitions and partnerships. They work at the criticalintersection where innovations that save and sustain lives meet the physicians, nurses and pharmacists who make it happen. Our client is committed to improving outcomes for patients, and helping their partners meet the evolving challenges and opportunitiesin healthcare around the world.
**The Location**:
Remote working.
**Rewards**:
As a PAYE employee you would be entitled to:

- Pension
- Timesheet system
- Paid holidays

**Senior Regulatory Affairs Associate Role**:

- Support the development/alignment of regulatory policies and strategies across all GBUs
- Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices in accordance with the business goals.
- Interpret existing, pending and proposed regulations/guidance documents
- Support the implementation of the RA management to ensure the regulatory requirements of BHSA are met.

**Your Background**:

- Degree in engineering or life sciences
- Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing in a medtech company.
- Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment.
- Excellent organizational skills including project management skills.
- Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54444 in all correspondence.

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