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For Companies At a Glance
- Tasks: Ensure compliance with regulatory standards and manage product design changes.
- Company: Join Olympus, a global leader in medical technology with over 100 years of innovation.
- Benefits: Enjoy competitive salary, private medical cover, and wellness perks like gym discounts.
- Why this job: Make a real impact on healthcare while working in a supportive and innovative environment.
- Qualifications: Degree in a scientific field and 2 years' experience in regulatory affairs or quality.
- Other info: We celebrate diversity and encourage all qualified candidates to apply.
The predicted salary is between 28800 - 42000 £ per year.
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
- Implement and ensure compliance with all applicable regulatory and quality requirements.
- Ensure adherence to all relevant Health, Safety, and Environmental standards.
- Generate and maintain technical documentation for regulatory compliance.
- Initiate change requests for updating IFU and labelling of the OKM portfolio.
- Review product and process change requests.
- Support regulatory compliance projects, such as EU MDR and NPD/sustaining projects.
- Drive process updates and contribute to process improvements.
- 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.
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Regulatory Affairs Specialist employer: OLYMPUS EUROPA SE & CO. KG
Contact Detail:
OLYMPUS EUROPA SE & CO. KG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device industry, particularly the EU MDR. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in regulatory affairs through platforms like LinkedIn or industry-specific events. Building connections can provide insights into the role and may even lead to referrals, increasing your chances of landing the job.
✨Tip Number 3
Prepare to discuss specific examples of your experience in change management and regulatory compliance during interviews. Highlighting your hands-on experience with product design changes will showcase your suitability for the role.
✨Tip Number 4
Research Olympus and their core values thoroughly. Be ready to articulate how your personal values align with theirs, especially around patient focus and integrity, as this will resonate well with the hiring team.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Specialist position. Tailor your application to highlight relevant experience in regulatory affairs, quality, or R&D within the medical device industry.
Highlight Relevant Experience: In your CV and cover letter, emphasise your minimum of 2 years’ experience in regulatory affairs and any specific projects you've worked on that relate to compliance with medical device regulations. Use concrete examples to demonstrate your understanding of the regulatory framework.
Showcase Your Skills: Make sure to showcase your excellent communication, negotiation, and organisational skills in your application. Provide examples of how you've effectively worked in a team environment and contributed to process improvements or change management.
Craft a Strong Cover Letter: Write a compelling cover letter that reflects your passion for the medical device industry and aligns with Olympus's core values. Discuss how your background and skills make you a perfect fit for the role and how you can contribute to their mission of improving lives.
How to prepare for a job interview at OLYMPUS EUROPA SE & CO. KG
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks applicable to medical devices, especially EU MDR. Be prepared to discuss how your experience aligns with these regulations and how you can ensure compliance in your role.
✨Showcase Change Management Experience
Highlight your experience in change management, particularly in product design processes. Be ready to provide specific examples of how you've successfully managed changes from start to finish.
✨Demonstrate Communication Skills
Since excellent communication and negotiation skills are crucial for this role, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated with teams or stakeholders in past projects.
✨Emphasise Team Collaboration
This position requires effective teamwork. Share examples of how you've collaborated with others in a team environment, focusing on your ability to contribute positively and support your colleagues.