Regulatory Affairs Specialist

Eagleston Financial Group; United Kingdom; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading healthcare firm in the UK is seeking a Regulatory Affairs Specialist. This role is pivotal in ensuring that their advanced wound care products meet global regulatory standards. Candidates should have a background in life sciences, experience with medical device regulations, and strong organizational skills. This position offers a hybrid working model and a range of benefits including health plans, generous bonuses, and flexible vacation policies.

Benefits

Generous annual bonus

Flexible vacation and time off

Private health and dental plans

Discounts on gyms and fitness clubs

Qualifications

• Experience with medical device regulations and submissions.
• Complete familiarity with regulatory submissions according to national requirements.
• Ability to manage projects with regulatory implications.

Responsibilities

• Manage project and regulatory involvement with supervision.
• Compile and review regulatory submissions for consistency.
• Review and approve product labeling and promotional materials.

Skills

Organisational skills

MS applications proficiency

Relationship building

Education

Background in life sciences

Job description

Life. Unlimited. At Smith+NEPhew we design and manufacture technology that takes the limits off living. Are you passionate about making a real impact in healthcare? Join us as a Regulatory Affairs Specialist and play a key role in ensuring our advanced wound care products meet global standards. This is your chance to influence innovation and help deliver life-changing solutions to patients worldwide.

What will you be doing?

Responsibilities

• Managing project and regulatory involvement with direct management supervision. This includes providing on‑going regulatory advice to project teams throughout the product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
• Compile and review, as required, regulatory submissions in accordance with national requirements to ensure appropriateness and consistency in content and presentation of information both within and between registration applications. This can include European Technical Files, US 510(k) applications and device listings as required.
• Complete the requirements of the Smith & Nephew regulatory submission plan per the requirements of RIMSYS (recording/tracking of regulatory submission application).
• Review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
• Review and approve change control impact assessments for products.

What will you need to be successful?

• A background in life sciences or similar discipline
• Experience with medical device regulations and submissions
• Strong organisational skills and proficiency in MS applications
• The ability to build effective relationships across teams and with external stakeholders

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and patients we serve.

Inclusion and Belonging

Committed to welcoming, celebrating and thriving on inclusion and belonging. Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com).

Your Future

Generous annual bonus and pension schemes, Save As You Earn share options.

Work/Life Balance

Flexible vacation and time off, paid holidays and paid volunteering hours, so we can give back to our communities!

Your Wellbeing

Private health and dental plans, healthcare cash plans, income protection, life assurance and much more.

Flexibility

Hybrid working model (for most professional roles).

Training

Hands‑on, team‑customised, mentorship.

Extra Perks

Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.

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