Senior Regulatory Affairs Specialist, West Midlands, Medical Devices

Recruiter
Meet Recruitment Ltd
Location
Worcester
Posted
11 Jan 2018
Closes
10 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Would you like to work for a family-owned medical device company who have a great working culture? My client are looking to increase their regulatory workforce further as their product range continues to grow. If you'd like great exposure to product registration and the new MDR, this would be the perfect role for you!

Senior Regulatory Affairs Specialist, West Midlands, Medical Devices

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Responsibilities:

- Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
- Produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with continuous improvement programmes and/or changes required through standards.
- Investigate, remediate and successfully conclude all regulatory issues that are product related.
- Support the regulatory team in processing global product registrations and approvals for chosen markets
- Support Risk Management activities
- Understand and apply quality assurance procedures in line with ISO 13485:2016 quality management system standards, the Medical Devices Directive 93/42/EEC (as amended) and Medical Device Regulation MDR 2017/745.
- Ensure personal compliance with internal regulatory, quality and other procedures.
- Ensure the company is compliant to global regulatory requirements for quality systems and product registrations / approvals including CMDCAS.

Skills Required:

- Minimum 5 years-experience in Regulatory Affairs within the Medical Device industry (MDD)
- Broad knowledge of post market activities
- Broad knowledge of quality systems and procedures
- Broad knowledge of global medical device regulations and international standards

Full job description and company details are available upon application, apply below. This position is being dealt with by Nathan Berkley at Meet, please call ************** You can also e-mail us directly at ****************************** to discuss in confidence.

Meet are good people who are great at recruitment. We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at ***************************