Senior Regulatory Affairs Specialist

Hunter Selection
Swansea
1 year ago
Applications closed

Related Jobs

View all jobs

Pharmacovigilance Officer

Senior Immunoassay Scientist

Senior Director, Search & Evaluation Ig TA Lead

Senior Director, Regional Ecosystem Lead (EMEA)

Senior Scientist

Senior Laboratory Manager

£40000 - £55000 per annum + Excellent company benefitsSwansea

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Remote / Hybrid

South Wales

23191/617

£40,000 – £55,000 and further benefits

What is on offer?

A salary of up to £55,000Remote working (Occasional travel to site depending on location)25 days holidays plus bank holidaysPension SchemeHealthcare cash planSick PayLife Assurance

An award-winning medical manufacturer in South West Wales is currently looking to strengthen its Regulatory team with the key acquisition of a Senior Regulatory Affairs Specialist. With investment secured for the next 5 years, this company is in a leading position to capitalise on the market. They are targeting significant growth this year after releasing a new product into market.

Senior Regulatory Affairs Specialist Role:

Monitor changes in global regulatory requirements and communicate their impact to the organisation. Develop and execute regulatory strategies for new and existing medical devices. Collaborate with cross-functional teams to ensure timely submission of documents and approvals. Maintaining and updating product technical files Prepare, review, and submit regulatory documents to health authorities, including 510(k), PMA, CE Mark, and international submissions. Work with cross-functional teams to resolve compliance issues and deviations. Collaborate with the Quality Assurance team to ensure that the quality system aligns with regulatory requirements (ISO 13485, FDA QSR, etc.). Coordinate and participate/host internal and external audits to assess compliance with regulatory standards.

What you need?

Bachelor’s degree in a relevant field (e.g., life sciences, engineering, regulatory affairs). Master’s degree is a plus. Ideally 4 -5 years of experience in regulatory affairs in the medical devices industry. Strong knowledge of global medical device regulations, including UKCA, CE marking, and regional requirements in ASPAC and LATAM markets.

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Jobs

CSL Behring Jobs UK: Careers, Salaries, Locations & How to Get Hired

CSL Behring is one of the world’s leading biopharmaceutical companies specialising in plasma-derived therapies, recombinant proteins, gene therapy, vaccines, and rare disease treatments. If you’re a UK job seeker looking for a career with real purpose, strong scientific standards, and long-term progression, CSL Behring roles can be an excellent fit, especially if you have experience in biotech, pharma manufacturing, quality, engineering, supply chain, clinical operations, regulatory, pharmacovigilance, or commercial. This guide is written for UK candidates who want to understand what CSL Behring jobs typically involve, which roles to target, where opportunities may be based, what skills recruiters look for, and how to tailor your application to stand out.

Careers

How Many Biotechnology Tools Do You Need to Know to Get a Biotech Job?

If you are trying to break into biotechnology or progress your career, it can feel like the list of tools you are expected to know is endless. One job advert asks for PCR, another mentions cell culture, another lists bioinformatics pipelines, automation platforms or GMP systems. LinkedIn makes it worse, with people sharing long skills lists that make you wonder if you are already behind. Here is the reality most biotech employers will not say out loud: they are not hiring you because you know every tool. They are hiring you because you understand biological systems, can work accurately and safely, follow protocols, interpret results and contribute reliably to a team. Tools matter, but only when they support those outcomes. So how many biotechnology tools do you actually need to know to get a job? The answer depends on the role you are targeting, but for most job seekers it is far fewer than you think. This article breaks down what employers really expect, which tools are essential, which are role-specific, and how to focus your learning so you look employable rather than overwhelmed.

Jobs

What Hiring Managers Look for First in Biotechnology Job Applications (UK Guide)

Hiring managers in biotechnology do not start by reading your CV word for word. They scan for credibility, relevance and risk. In a regulated, evidence-driven sector like biotech, the first question is simple: is this person safe, competent and genuinely capable of contributing in this environment? Whether you are applying for roles in research, manufacturing, quality, regulatory, clinical, bioinformatics or commercial biotech, the strongest applications make the right signals obvious in the first 10–20 seconds. This in-depth guide explains exactly what hiring managers in UK biotechnology look for first, how they assess CVs, cover letters and portfolios, and why capable candidates are often rejected. Use it as a practical checklist before you apply.

🍪 We use cookies to enhance your browsing experience on our website. By continuing to use this site, you consent to the use of cookies as described in our Cookie Policy. You can review our Cookie Policy for more information.