Are you a proactive regulatory professional looking to lead critical compliance activities in the life sciences sector? We are seeking a Sr. Regulatory Affairs Specialist to join a dynamic international team for a 12-month contract. This role offers the flexibility of remote or hybrid working and is based out of Warrington.
The Role
In this leadership-focused position, you will provide hands-on support for EU Member State notifications concerning IVDR CDx performance studies. You will be responsible for developing regulatory application strategies that align with business objectives, ensuring timely submissions and maintaining full regulatory compliance across the EMEA region.
Your Responsibilities
- Notification Management: Lead and manage notification activities for IVDR CDx performance studies involving leftover samples.
- Documentation & Submission: Prepare, review, and submit notification packages to EU Competent Authorities and Ethics Committees
- Cross-Functional Collaboration: Partner with Clinical, Medical, Legal, Quality, and Project Management teams to ensure submissions are both compliant and timely.
- Regulatory Liaison: Act as the primary point of contact for EU regulatory authorities, responding to inquiries and requests for additional information.
- Strategic Guidance: Provide regulatory expertise to project teams regarding study design and documentation requirements
Key Details
Pay Rate: £80.00 per hour.
Duration: 12 months.- Hours: 37.50 hours per week (Mon-Fri, flexible hours between 09:00 and 18:00).
- Travel: Approximately 10-15% willingness to travel.
- Equipment: Laptop and accessories will be provided
What We Are Looking For
Education: A Bachelor's degree in Life Sciences, Biomedical Sciences, or a related field.
Experience: At least 3+ years in Regulatory Affairs or Clinical Regulatory functions within the IVD, medical device, or pharmaceutical industry- Expertise: Solid working knowledge of IVDR ($EU2017/746$), particularly regarding performance studies.
- Regulatory Track Record: Proven experience with EU regulatory submissions and interactions with Competent Authorities.
- Soft Skills: Strong project management abilities, excellent English communication skills, and the ability to work autonomously in a matrixed environment
To apply, please click on the apply button.
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.
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