Regulatory Affairs Specialist

Regulatory Affairs Specialist II - Remote
Full-Time | 37.5 Hours per Week

My client is a leading provider in the diagnostics industry, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. Their work provides critical information for the treatment and management of diseases and other health conditions.

We are currently seeking a Regulatory Affairs Specialist II within the Infectious Disease business unit. In this role, you will be responsible for preparing documentation for international product registrations.

This job description will be reviewed periodically and is subject to change by management.

Responsibilities:

1. Prepare technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation (IVDR).
2. Provide regulatory support for diagnostic product development and commercial diagnostic products.
3. Perform regulatory impact assessments to ensure compliance with international regulations and timelines.
4. Coordinate with internal and external stakeholders to gather necessary information.
5. Maintain up-to-date knowledge of regulatory changes and industry standards.
6. Develop regulatory strategies for new and modified products to achieve international clearance/approval.
7. Support regional regulatory teams with submissions, license renewals, and amendments.
8. Research and communicate scientific and regulatory information to support submission documents.
9. Compile and publish all material required for submissions, renewals, and annual registrations.
10. Maintain approvals/licenses/authorisations for existing marketing authorisations.
11. Assess product, manufacturing, and labelling changes for regulatory impact and compliance.
12. Develop internal procedures and tools to enhance regulatory processes.
13. Conduct informational or training sessions for stakeholders.
14. Organise and maintain both hard copy and electronic department files.
15. Demonstrate commitment to the development and effectiveness of the company's Quality Management System per ISO, FDA, and other regulatory agency requirements.
16. Exhibit professionalism with internal and external business associates in alignment with company policies.

Basic Qualifications | Education:

1. Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or equivalent experience.
2. 4+ years of experience in a Regulatory Affairs role.
3. Strong knowledge of IVDR, EU, and international regulatory requirements.

Preferred Qualifications:

1. 1+ years of experience in an IVD or medical device manufacturing environment.

Competencies:

1. Strong knowledge of EU and international regulations.
2. Excellent written and verbal communication skills.
3. Strong time management skills with the ability to manage multiple projects simultaneously.
4. Ability to work both independently and within a team.
5. Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Visio.

How to Apply:
To apply, please click the button or contact Danielle at (phone number removed).

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.