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RA Manager - Registrations

Location: Coventry Salary: Negotiable
Sector: Medical Devices Type: Permanent
Contact: Matt Henocq Job Published: 12 days ago

RA Manager - Registrations

About the Company:

We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing. This role is responsible for leading the delivery of the company's product submissions strategy. This will be achieved through driving global submission management activities for company products and supporting business global efforts to ensure high quality and successful submissions.

Deliverables include:

  • Responsible for supporting the business with translation of the regulatory requirements into business language when required
  • Responsible for communicating all the regulatory requirements for registrations and renewals to the business in a timely manner
  • Investigate and define new products approbation pathway and requirements as well as preparing submissions dossiers for defined markets
  • Keeping abreast of international legislation and guidelines to facilitate market entry and communicating this to the business
  • Communicating with the local authorities/local distributors to ensure on time registration of products.
  • Monitoring and setting timelines for license renewal/approvals including maintaining companies' device listing and establishment registration with FDA
  • Advising internal stakeholders of regulatory requirements including time and cost of registration
  • Providing country specific regulatory requirements for product registration throughout the development of a product
  • Be a key participant of product and business development teams and relevant meetings to advocate deliverable timelines, project strategy and assess the global submissions delivery activities
  • Specifying storage, labelling, and packaging requirements in line with international registration requirements
  • Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice
  • Line management of the Registrations team and delivery of any other duties as required by the Director of RAQ or the business.

Key competence / skills / abilities:

  • Regulatory, science or engineering degree or equivalent, plus appropriate experience in regulatory affairs
  • Sound medical device experience, including a successful track record in the registration and maintenance of products within international markets
  • Sound knowledge of relevant Quality Standards
  • Ability to gather, analyze and interpret regulatory information and changes in the regulatory landscape, taking ownership for delivery.
  • Pragmatic team member and flexibility to work within the dynamics of a cross-functional team.
  • Great communication skills.

Desirable Additional Experience:

  • Experience of managing people in a similar role, with the ability to lead, influence, and motivate a team.
  • Networking abilities with internal and external stakeholders (competent authorities and registration bodies).
  • Strategic and analytical thinking & highly Structured way of working.
  • Comprehensive knowledge of processes and regulations in medical device and drug development; combination product (device-device), drug Masterfile compilation experience is highly desired.
  • Strong communication skills, goal- and solution orientation, flexibility, and assertiveness.
  • Medical device or pharmaceutical product manufacturer experience.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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