fbpx
Home > Life Sciences > Head of Regulatory Affairs

Job Reference: HH/HQ1231

Head of Regulatory Affairs

  • Gloucester, Gloucestershire, England
  • Permanent / Full Time
  • Life Sciences Team
  • £75000 - £80000

Job Title: Head of Regulatory Affairs

Location: Gloucestershire

Package: Up to £80k

Role type: Full time, permanent

Job Purpose

Ensures business compliance to legislation and quality standards in support of the Company’s overall goals for the delivery of cost effective, high quality products and excellent customer service.

Key Responsibilities

  • Ensures the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, ISO9001, MDD 93/42/EEC, Regulation (EU) 2017/745 and ISO14971)
  • Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory requirements (21 CFR 803)
  • Collates, updates and maintains product registration information (including Product Technical Files, Quality/Technical Agreements, 510(k) files and DMR’s)
  • Liaises with external parties (Notified Bodies, Competent Authorities, FDA, etc.) on regulatory matters
  • Ensures the implementation and maintenance of a documented Quality Policy, procedures, principles and processes to reflect best practice and compliance to relevant regulatory/statutory requirements
  • Manages and coordinates group regulatory requirements such as FDA/CE registration, country of origin regulations, labelling and IFU standards, etc.
  • Stays up to date on global regulatory developments and keep executive team informed
  • Acts as the company representative in the global regulatory environment, including regulatory engagement with customers.
  • Ensures that the business is audit ready at all times, including unannounced audits
  • Builds and maintains corporate technical and regulatory policies and act as a bridge between ‘policy’ and ‘operational’ implementation via the site QA teams.
  • Audits the site quality function, to confirm compliance with company and industry standards
  • Coordinates compliance in relation to R&I (Research and Innovation) and NPD (New Product Development).
  • Plans and delivers the Regulatory registration / submission documentation required to achieve global market access.  Ensuring business activities are conducted in compliance with the regulations and standards applicable to our business and product range i.e. Product Registrations within Russia, Mexico etc.
  • All employees are expected to undertake reasonable tasks as required to ensure company targets are met

Qualifications & Experience

  • 5 – 10 years regulatory experience
  • Medical device experience is essential
  • MDR experience is strongly desirable
  • Level 5 qualification in Management desirable
  • Has experience of certifying body such as TUV Sud

Personal Qualities

 

  • Strong transformational leadership and interpersonal skills
  • Passion for quality, delivery, and continuous improvement
  • Excellent communication skills to disseminate information verbally and in writing to technical and non-technical people
  • Excellent negotiation skills to influence and drive change through others (internally and externally)
  • Strong analytical, problem solving and project management skills and attention to detail

Working Environment

  • This role is office based (with some remote working available)
  • The nature of the work requires a willingness to undertake national and international travel and have a flexible approach to working hours.

If this role is of interest, please click apply now. If you’d like more info, please contact Harvey in the Life Sciences team.

Earn £250 when you refer a friend or colleague!

Find Out More