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Job Details

QA & Medical Device Specialist *** Global Safety Surveillance Leadership Role *** Grow and then lead a team!!! *** Near Gent

Company: Advanced Regulatory (UK & Europe)
Location: Gent Area, Belgium
Reference: MGADV / 10344
Closing Date: 09 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: On Application

Job Summary:

If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.

Requirements:

QA & Medical Device Specialist *** Global Safety Surveillance Leadership Role *** Grow and then lead a team!!! *** Near Gent

My client is dynamic and quickly growing Global Pharmaceutical focused on developing medicines and healthcare products across a wide variety of therapy areas, formulations and geographical regions for over-the-counter, nutritional products, active pharmaceutical ingredients and Medical Devices. Based at their new European Quality and PV Hub in Belgium, they are now looking for an experienced Medical Device Specialist to take the lead in a Global Safety Surveillance Role which will also grow into a team leading position.

You will represent Post-Market Medical Device Vigilance operation in front of HA, notified body, internal and external audits and perform queries to provide complaint and ad hoc trend analysis on reported medical device safety complaints.

You will be a key member of the Global Safety Surveillance team and you will work closely with cross-functional team members including Quality Assurance and Regulatory Affairs. You will have a clear understanding of all medical device safety complaint handling processes as well as required regulatory reporting procedures for local and international products.

Your roles and responsibilities will also include:

  • Responsible for day to day functions including data management/Complaints handling of medical devices safety
  • Ensures data is accurate, timely, relevant, and complete.
  • Lead and Facilitate the investigation of complex safety complaints
  • Submit and write Medical Device Vigilance Reports to HA and Authorized Representatives/Notified Bodies
  • Interface with distributors, sales force, international representatives, and in-house departments for safety complaint information
  • Represent Post-Market Medical Device Vigilance operation in front of HA, notified body, internal and external audits.
  • Performs queries to provide complaint and ad hoc trend analysis on reported medical device safety complaints.

Desired Skills and Experiences:

  • Experience in Medical Device post-market vigilance (complaint handling & management) is required
  • Experienced in Medical Device Reporting (MDR’s)
  • Experienced in Medical Device Vigilance (MDV’s)
  • Prior experience working within the medical device industry
  • Strong analytical skills including trend and statistical analysis

In return for making a significant contribution, the company are offering a competitive package and for applicants requiring in to country relocation, a very supportive relocation policy.

To be considered for the above roles (available to any individual eligible to work in the EU including those individuals requiring relocation) please call Theo Moore or Matt Greig, on +44(0)207 801 3384 or +44(0)7918 195 166, alternatively send a full CV to Cv@advregulatory.com

Advanced Referral Scheme - We also offer an iPad 3 for any referrals that we help to place into a new role so if this role isn’t for you, then please think about referring a friend or colleague…Many thanks…!!!

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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, QA, Quality Assurance, Drug Safety, Safety Specialist.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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