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Job Details

Senior Regulatory Affairs Specialist - £45-60k – Gloucestershire – Medical Devices

Company: Meet
Location: Cirencester, Gloucester, Gloucestershire
Reference: NB-RAS-Glouc
Closing Date: 29 Sep 17
Type: Permanent
Salary (£): Negotiable
Benefits: Relocation

Job Summary:

Would you like the chance to work with products from the ground up, with all classifications of devices? This company, who have just undergone an acquisition of another, allows you the opportunity to do just that. With the continual investment in new technology, this company remains at the forefront of innovation. Along with a competitive salary, they also offer relocation for this role.

Requirements:

Senior Regulatory Affairs Specialist, £45-60k, Gloucestershire, Medical Devices

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Duties and Responsibilities:

  • Liaise with company R&D and Product Management teams to provide regulatory input into NPI Project Core teams.
  • Timely preparation and submission of regulatory applications and registrations as assigned (e.g. Design Dossier, Technical Files, 510(k), IDE supplements, annual reports, PMA and PMA supplements).
  • Regulatory aspects of post market surveillance.
  • Regulatory submissions and filings as assigned.

Skills Required:

  • Degree level education in a life science subject.
  • Detailed knowledge of the regulations and guidance for global markets.
  • Understanding of Quality Management Systems - FDA QSR, ISO 13485.
  • Minimum 5 years' experience in medical device regulatory affairs.

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 0203 019 6020. You can also e-mail us directly at nathan@peoplewithchemistry.com 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 www.peoplewithchemistry.com

Key Words

21 CFR (820, 210 and 11), MDD (93/42/EC), ISO 13485, Medical devices, Orthopedics, Regulatory Affairs, Regulatory Affairs Officer Jobs, Regulatory Affairs Specialist Jobs, Medical Device Jobs, Regulatory Affairs Associate Jobs, Regulatory Affairs Associate, Regulator Affairs Officer, Regulatory Affairs Specialist, Medical Device, Gloucester, Gloucestershire, South West England, Cirencester

Apply for this job: Senior Regulatory Affairs Specialist - £45-60k – Gloucestershire – Medical Devices

Contact Information:

Address:  meet
Irongate House, 30 Dukes Place, London
EC3A 7HX
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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