Senior Regulatory Affairs Officer

A client of mine is seeking a regulatory affairs officer with medical device experience to join them on a contract basis.

Job Title: Senior Regulatory Affairs Officer

Key Responsibilities:

Be the primary RA representative for the Immunodiagostics products

Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of products as necessary

Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products

Be responsible for the planning and implementation of new and updated regulations as applicable to products while working in coordination with global regulatory affairs

Assist Line Manager in gathering relevant KPI and metrics

Lead change projects and site quality review meetings

Minimum Requirements/Qualifications:

Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs

Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred.

Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice

Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment

Ability to coordinate and manage the completion of multiple projects simultaneously

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines

Strong organizational and follow-up skills, as well as attention to detail

Ability to travel within UK and internationally as required

Non-Negotiable Hiring Criteria:

Proven experience in RA in IVD or medical devices companies

Experienced in 510(k) submission or Technical File compilation

Demonstrated experience in navigating complex pre-market submissions.

Experience working in a broader enterprise/cross-division business unit model preferred

Vacancy Summary:

Location: South East England

Job Type: Permanent

Salary: £54,000 – £60,000

If you are interested in this role or know anyone who might be please respond with an up to date CV and I will be in touch ASAP.

Also, please feel free to join my LinkedIn group, created specifically for roles within Regulatory Affairs (Link Below).