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Salary£60000 - £70000 per annum
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LocationNewmarket
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TermPerm

We are delighted to be working with one of the region’s leading, rapidly expanding medical businesses to recruit a newly create Regulatory Affairs Specialist. 

The successful candidate shall be responsible for the regulatory activities for the legal manufactured products associated with IVD medical devices development through the R&D phase and the verification and validation phase through launch and post marketing arena.

Activities such as requirements generation document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day development and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development.
 
The Role
  • Independently create and maintain product technical files and product design dossiers.
  • Participate in project teams to provide regulatory input into cross-departmental product development and international registration projects.
  • Prepare documentation and product registration dossiers in order to support Global regulatory submissions. Defend the submitted dossiers with the relevant authority.
  • Engage on the activities related to the Person Responsible for Regulatory Compliance.
  • Facilitate the understanding of regulatory requirements throughout the business, by means of supporting other areas and entities, providing training and support as required.
  • Carry out in-depth work with relevant experts to develop study definition and design to obtain validation and verification data; commission studies with subsequent collation and recording of data and reports in readiness for the preparation of applications to regulatory authorities under the requirements of the relevant legislation for each product. 
  • Maintain and update existing worldwide authorisations, acting as the company’s representative in directly managing interactions with regulatory authorities, internal and external customers.  Global experience, (with a specific focus on EU requirements), in Medical Devices and CER for Medical Devices. Working knowledge of MDR implementation with a focus on clinical requirements
  • Developing strategies and document preparation for products marketed globally and as designated by management for the preparation of applications to regulatory authorities under the requirements of the relevant legislation for each product type
  • Ability to work alongside the European Authorised Representative in all matters concerning their requirements under the MDD and MDR.
  • Assist marketing in preparing product manuals or technical materials upon request, advise marketing on labelling, literature and advertising regulatory requirements.
This position has a strong internal and external customer service focus together with a substantial project and process management. It is a versatile and multifaceted role involving work with multi-disciplinary environment and teams: regulatory affairs specialists, quality assurance, product development, technical, validation, quality control, sales and marketing.
About You
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication, along with the following skills and experience:
 
  • 2+ years of experience in Regulatory Affairs within the medical device industry is a must.
  • Work experience with the Medical Devices Directive and/or Medical Devices Regulation is a requirement.
  • Detailed knowledge of regulatory requirements in the USA, MEA, APAC or LATAM is highly desirable.
  • Experience in quality management compliance with ISO 13485 and/or ISO 9001 is a plus.
  • High degree of accuracy, concentration, verbal and written communication.
  • Ability to work without direct supervision/on own initiative to ensure that the business goals are achieved in a timely and efficient manner, and in adherence to all relevant regulatory requirements.
 
On offer is the chance to working for a unique and growing business in a sector that really does save people’s lives.
This is an international business offering an excellent salary and benefits package with hybrid working and close access to offices just off the A14.
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