Regulatory Affairs Specialist

OLYMPUS EUROPA SE & CO. KG; Southend-on-Sea; On-site; GBP 35,000 - 45,000; Full time

Job summary

A leading company in the medical device industry is seeking a Regulatory Affairs Specialist. This role involves ensuring compliance with regulatory standards and maintaining documentation while supporting key projects in product design. Candidates should possess a scientific degree and relevant experience in regulatory affairs.

Benefits

Competitive salary with generous annual leave

Private medical cover eligibility

Comprehensive pension scheme

Annual health check funded by the company

Employee Assistance Program

Subsidised staff restaurant and free parking

Discounted gym memberships and retail discounts

Qualifications

• 2 years experience in regulatory affairs, quality, or R&D within medical devices.
• Good understanding of regulatory framework for medical devices.
• Experience in change management for product design.

Responsibilities

• Ensure compliance with regulatory and quality requirements.
• Generate and maintain technical documentation for compliance.
• Drive process updates and improvements.

Skills

Communication

Negotiation

Organizational skills

Teamwork

Proficiency in MS Office

Education

University degree in Biomedical Science, Pharmacy, Engineering or similar

Job description

Regulatory Affairs Specialist

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Chief Quality Officer

A global leader in the medical device and technology industry, Olympus has been focused on making people's lives healthier, safer, and more fulfilling for over 100 years. Our products and solutions help diagnose, prevent, and treat illnesses, support scientific research, and ensure safety.

Olympus UK & Ireland (UI) is one of the largest and most profitable regions in EMEA. As both a Legal Manufacturer and Sales Center, we have a passionate workforce of nearly 1,000 people developing and advancing medical technologies, supporting both public (NHS/HSE) and private healthcare customers across the region.

Your responsibilities

1. Implement and ensure compliance with all applicable regulatory and quality requirements.
2. Ensure adherence to all relevant Health, Safety, and Environmental standards.
3. Generate and maintain technical documentation for regulatory compliance.
4. Initiate change requests for updating IFU and labelling of the OKM portfolio.
5. Review product and process change requests.
6. Support regulatory compliance projects, such as EU MDR and NPD/sustaining projects.
7. Drive process updates and contribute to process improvements.
8. Own change management within product design processes.

Qualifications

• University degree in a scientific discipline such as Biomedical Science, Pharmacy, Engineering, or similar.
• Minimum of 2 years’ experience in regulatory affairs, quality, or R&D within the medical device industry.
• Good understanding of the regulatory framework applicable to medical devices.
• Experience in change management, particularly ownership from start to finish of product design changes.
• Excellent communication and negotiation skills.
• Strong organisational skills.
• Ability to work effectively in a team environment.
• Proficiency in MS Office (Word, Excel, PowerPoint).

Our Core Values

• Patient Focus: We prioritize patients in everything we do.
• Integrity: We act ethically and responsibly.
• Innovation: We seek new ways to improve.
• Impact: We take accountability and deliver results.
• Empathy: We care for one another and collaborate effectively.

Benefits

• Competitive salary with a generous annual leave entitlement.
• Private medical cover eligibility.
• Comprehensive pension scheme.
• Annual health check with BUPA, funded by the company.
• Employee Assistance Program supporting health and wellbeing.
• Subsidised staff restaurant and free parking at HQ.
• Discounted gym and wellness memberships, cashback, and retail discounts.

Further Information

We value diverse perspectives and encourage all qualified candidates to apply, regardless of gender, nationality, ethnicity, religion, age, disability, sexual orientation, marital status, or other protected characteristics.