Senior Regulatory Affairs officer

  • Location

    London

  • Sector:

    Pharmaceutical

  • Job type:

    Permanent

  • Salary:

    £45,000

  • Contact:

    Peter Rowland

  • Contact email:

    peter@rowlandtalent.co.uk

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    RT1421

  • Published:

    over 1 year ago

  • Expiry date:

    2018-05-10

Rowland Talent Solutions are currently looking for a Senior Regulatory Affairs officer for an international Bioscience company based in London. Joining the company, you will have responsibilities for pre, and post-commercialisation activities related to product registration of In-Vitro Diagnostic products in accordance with Regulations as required for the EMEA region.

 

Responsibilities include:

 

  • Product Registration; compiling technical files and technical documentation to relevant authorities to support timely and efficient delivery to market
  • Maintaining product submissions for products across the EMEA region, including product changes, Re-registration, Labelling updates and Translations
  • Providing regulatory direction and strategy aligned to marketing plans
  • Oversight of the post-market surveillance actions and communications for product feedback and improvements.
  • Manage risk management files for all products in accordance with the IVDR
  • Implementation and management of vigilance activities including; Recalls, Field Corrective Actions, etc.
  • Manage the database.
  • Sales and Marketing material review for labelling claims and compliance to harmonized and national standards, liaising with colleagues and product suppliers as required.
  • Be part of the key resource group to audit distributors and product suppliers as required
  • Support departments and partners as EC Representative

 

Ideal candidates will have a Degree in Biology or Biochemistry (Or related subject) and have expert knowledge in In-vitro Diagnostics Directive/Regulations, ISO13485 and ISO14971 standards.

To be successful in this role you will:

  • Be familiar with electronic documentation systems.
  • Have experience in the writing Product Submission and Technical Files, and implementing of Policies, Procedures, Work Instructions and Forms.
  • Be competent in producing training programs to communicate regulatory requirements
  • Have high standards of written work and good attention to detail.
  • Be fluent in English and ideally Italian (desired but not essential)
  • Have flexibility to travel to Italy on a regular basis (6-8 times a year for a few days each time).