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Regulatory Affairs Specialist

Job Posted: 21 days ago

Salary: £ Competitive
Job Type: Temporary
Location: Warrington, Cheshire

Expire in: 7 days

Job Description

Senior Regulatory Affairs Specialist (EMEA)

Location: Warrington (Remote or Hybrid options available) Duration: 12-Month Contract Pay Rate: £50.00 - £60.00 per hour Work Pattern: Monday - Friday, 37.5 hours per week (Flexible hours between 09:00 and 18:00)

The Role

We are seeking a high-energy Senior Regulatory Affairs Specialist to provide leadership and strategic support for IVD/MD (In Vitro Diagnostic and Medical Device) registrations across the EMEA region. Reporting to the Director of Regulatory Affairs EMEA, you will work within a dynamic, international environment to ensure market growth and revenue protection through strict regulatory compliance.

This is a versatile role that can be performed remotely or as a hybrid arrangement out of our Warrington site, with occasional business travel (approx. 10-15%) for escalations and site visits.

Key Responsibilities

Registration Leadership: Lead national product and establishment registrations across EMEA markets, ensuring all timelines are met.
Strategic Planning: Develop and execute regional registration strategies that align with global commercial objectives.
Stakeholder Management: Maintain professional relationships with regulatory authorities and third-party distributors to facilitate smooth submission processes. 
Compliance & Intelligence: Monitor and interpret evolving EMEA regulations, providing impact assessments and guidance to legal manufacturers.
Data Integrity: Maintain and update regulatory databases and activity trackers to ensure full traceability of technical documentation. 
Process Improvement: Use Practical Process Improvement (PPI) tools to streamline request management and train internal stakeholders.

Required Qualifications & Skills

Experience: 8-10 years of Regulatory Affairs experience specifically within the IVD or Medical Device sectors in the EMEA region. 
Regulatory Knowledge: Deep expertise in ISO13485 Quality Systems, as well as European IVD and MD regulations.
Geographic Reach: Proven track record of successful registrations across Europe, the Middle East, and Africa. 
Technical Proficiency: Ability to understand and communicate complex scientific principles related to reagent chemistry, laboratory automation, and software components.
Soft Skills: A proactive, "hands-on" leader who is comfortable with ambiguity and thrives in a matrix-managed organisation.
Communication: Excellent oral and written English skills, with the ability to collaborate effectively across different time zones (US, Europe, and Asia)

Interview Process

Stage 1: Initial interview via Microsoft Teams. 

Stage 2: Final interview conducted on-site

Equipment Note: A laptop and necessary accessories will be provided for this role

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

Before You Apply

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Bank details.
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Date of birth.

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