£40 - 55 per hour
4 months ago
My client, a global medical devices company based in Hull are looking for a Senior Regulatory Affairs Specialist. This role will be a 12-month contract, with the ideal candidate available to start in February 2020.
Job Title: Senior Regulatory Affairs Specialist
About the role:
To provide regulatory expertise to ensure that regulatory approvals are obtained and maintained in accordance with the agreed registration programme and the needs of the business plans. Particular focus upon the new European Medical Device Regulation (MDR).
- To compile, review and approve, as required, regulatory dispatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications. Particular focus upon the new European Medical Device Regulation (MDR)
- To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
- To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
- To review and approve change control impact assessments for products.
- Eligibility to work in the UK
- An honors degree, in a science subject or equivalent industry experience.
- At least 5 years related experience
- Minimum of 3 years regulatory experience or equivalent within a regulatory compliance function.
- Good interpersonal skills are essential
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to firstname.lastname@example.org or call 0203 589 9294 for a confidential discussion about potential opportunities.
NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?
Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.
Catalyst Life Sciences:
Catalyst Life Sciences are a global recruitment company specialising in the the Life Sciences industry. With specialist consultants working with a network of skilled industry professionals based on their skill set, we are well placed to understand in detail and deliver on time across roles of all levels within our niches. This includes the following markets;
- Pharmacovigilance/Drug Safety
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Medical Information
- Medical Writers
- Medical Affairs
- Clinical Trials
- Clinical Research
- Project Management
My LinkedIn Profile:
I personally specialise in recruiting RA professionals for roles across the UK so please do get in touch should you be considering new roles or looking to fill ones at your current company!