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Job Details

Regulatory / RA / CE Marking / Technical Files / Submissions / Pre-market Approvals / FDA / MHRA

Company: X4 Group
Location: Hampshire
Reference: JL2411
Closing Date: 22 Dec 16
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices Salary: £35,000 - £45,000Location: Surrey, commutable from Oxfordshire, Hampshire, Wiltshire  Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices specialist needed to join a growing medical device manufacturer. This Medical Device / ISO 13485 company are looking to introduce their Class IIb medical device product into the US and Asian markets. ...

Requirements:

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices

Salary: £35,000 - £45,000

Location: Surrey, commutable from Oxfordshire, Hampshire, Wiltshire

 Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices specialist needed to join a growing medical device manufacturer. This Medical Device / ISO 13485 company are looking to introduce their Class IIb medical device product into the US and Asian markets. As one of the representatives for the regulatory team, you will be required to aid and support CE Marking Submissions and to guide the company through the EMEA registration.

This position provides an exciting opportunity where you will be able to progress your career within the Regulatory industry and provides genuine rapid career progression to a managerial level.

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices – Key responsibilities:

  • Assist with all CE Marking Submission applications for US and Asian markets
  • Support and provide guidance for EMEA registration
  • Prepare all future 510(k) submissions for FDA approval
  • Ensure all dossiers are technically accurate
  • Provide regulatory support to supply and marketing in accordance to specific market regulations
  • Provide training and liaise with all relevant departments to ensure complete compliance to all regulatory standards.

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices – Key Experiences

  • Must have proven working knowledge as a Regulatory Professional for a minimum of 3 years
  • Must have at least 3 years experience within an ISO 13485 environment
  • Experience of FDA, MHRA, MDD is also highly advantageous
  • Degree level or equivalent experience with either a Scientific, Management, Quality  or Engineering background is highly desirable

The ideal individual for the position will either have a strong academic background who is looking for rapid progression within the regulatory industry or an experienced professional who is looking for the exciting challenge of assisting with the fast expansion of the company.

If you would like to apply for this role please forward your CV to Lauren Harris at the X4 Group or call Lauren on 02078127700.

Key Skills: Regulatory / RA / CE Marking / Technical Files / Submissions / Pre-market Approvals / FDA / MHRA / MDD / 510(k) / US / Asian / EMEA

Apply for this job: Regulatory / RA / CE Marking / Technical Files / Submissions / Pre-market Approvals / FDA / MHRA

Contact Information:

Address:  Head Office
2nd Floor, Brettenham House
Lancaster Place,
London,
WC2E 7EN
England
Tel:  02078127700
Website:  Visit Our Web Site

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