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VP of Regulatory Affairs Medical Devices UK

Permanent / London

up to

VPof Regulatory Affairs

Recruiting for a VP of Regulatory Affairs for our client who is a leading medical device company with offices globally. The company designs, develops and manufactures its own products for the global market.

Responsibilities:

  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
  • Responsible for Company's compliance with regulatory agencies and all applicable standards worldwide
  • Assist in Clinical Studies required for Regulatory Approvals, including clinical study design, data analysis, and data reduction
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues
  • Represent the Company before regulatory authorities
  • Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities
  • Responsible for the review and approval of promotional, advertising, and labeling items
  • Assist in the Compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agencies

Requirements:

  • Minimum of 15+ years progressive experience in Regulatory Affairs
  • Bachelor's degree, preferably in life sciences, engineering, or business
  • Excellent track record for product clearances worldwide
  • Experienced in cGMP and other regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration
  • Good conceptual, analytical, problem solving, and organizational skills
  • A 'hands-on' individual who enjoys challenge, is capable and dedicated to getting the job done
  • An assertive, take-charge, proven manager with a strong results orientation, positive 'can do' attitude, and a sense of urgency to get things done
  • A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization
  • Well-organized and accustomed to maintaining excellent records

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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About us

Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

Contact

info@life-science.co.uk

0044 (0) 207 421 0000

0049 152 1164 1635

Resourcing Life Science Ltd.
Clerkenwell Workshops,
27/31 Clerkenwell Close,
London
EC1R 0AT