IVDR Regulatory Affairs Specialist

Do you consider yourself to have strong organisation skills? Are you able to oversee product cycles from beginning to end? If so, we are looking for an individual who would be interested in joining a global medical device company as a Regulatory Affairs Specialist. You would be supporting across global patches with tasks ranging from international registration of products to impact assessments.

Role details:

Title: Regulatory Affairs Specialist

Start Date: ASAP

Pay rate: £121,000 per annum (Depending on experience)

Hours: 37.5 per week (Full Time)

Location: Remote

Main Responsibilities include:

• Providing regulatory support for both diagnostic product development and commercial diagnostic products.
• Performing regulatory impact assessments.
• Develop regulatory strategies for products in development and for modified products to achieve clearance/approval internationally.
• Providing regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Research and communicate scientific and regulatory information to draft submission documents.
• Compile and publish all material required for submissions, license renewals, and annual registrations.
• Maintaining approvals, licenses, & authorisations for existing marketing authorisations.
• Assess product, manufacturing, and labelling changes for regulatory reporting impact and compliance to regulations.

Person Specification:

• Proven experience within Regulatory Affairs Position.
• Strong knowledge of IVDR, EU and international regulatory requirements.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
• Strong organisation & time management skills, with the ability to work on multiple projects simultaneously.
• Good knowledge of EU and international regulations.

Qualifications:

• Preferably 3+ years experience within Regulatory Affairs.
• Degree, preferably in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.

If you are interested in pursuing this position as a Regulatory Affairs Specialist then please don't hesitate to apply today!

Randstad Business Support is acting as an Employment Business in relation to this vacancy.