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Regulatory Affairs Executive, Medical Devices

Job Title: Regulatory Affairs Executive, Medical Devices
Contract Type: Permanent
Location: Hemel Hempstead, Hertfordshire
Industry:
Salary: Negotiable
Reference: J900682_1559306413
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: May 31, 2019 13:40

Job Description

Regulatory Affairs Executive, Medical Devices

Type: Permanent

Location: Watford

Hours: Days

Salary: upto £37,000 PA plus bonus, healthcare, pension etc.

Our Client, a major Medical Devices company who are experiencing significant growth at this time; are looking to appoint a RA Exec, who will play a key role in the development of the department and venture into new product ranges.

The Role:

This involves maintaining an awareness of regulatory requirements, advising the business on regulatory topics and supporting NPD projects teams to obtain relevant registrations, clearances and licences.

  • Supporting registrations and licences in line with relevant regulatory frameworks to enable product sales. This includes organising any necessary testing; submission of dossiers and also ensuring suitability of product labelling.
  • Maintaining an awareness and ensure compliance with relevant regulations and laws in all markets.
  • Monitor and communicate changes to applicable regulatory requirements
  • Manage REACH tonnage reporting
  • Track / report on assigned projects i.e. timelines/ costs
  • Liaising with relevant country contacts Medical Devices
  • Ensuring regulatory compliance of product labelling and also advertising
  • Managing relevant technical documentation and files
  • Interacting with consultants as and when required
  • Reviewing technical documentation from all sources to ensure regulatory requirements are met i.e. R+D/external labs /consultants
  • Handling post market reporting (Vigilance) Pharmaceutical
  • Preparing and submission of registration dossiers (using third parties as necessary).
  • Interacting with and advising project teams as assigned
  • Responding to enquiries from internal and external stakeholders
  • Providing advice on quality and regulatory requirements to key stakeholders as appropriate.
  • Supporting general responsibilities of the regulatory department
  • Working with external stakeholder contacts i.e. regulatory and certification agencies, industry organisations and business partners
  • Manage BPR dossiers
  • Author of SDS
  • Conducting CLP assessments
  • Interactions with Notified Body

The Person:

  • Will hold a Degree in a relevant, Scientific discipline
  • Will have experience working in an RA based role in a Medical Devices (iso 13485 setting)
  • Having an understanding in infection control/Microbiology is highly desirable
  • Good Project Management experience and experience in Microsoft applications.
  • Strong interpersonal / communication skills, with the ability to asses and translate technical data.

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