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- Tasks: Implement regulatory requirements and maintain compliance documentation for medical devices.
- Company: Join Olympus Corporation, a leader in medical equipment manufacturing focused on innovation and patient care.
- Benefits: Enjoy competitive salary, private medical cover, generous leave, and wellness perks.
- Why this job: Be part of a team that values integrity, innovation, and making a real impact on patient lives.
- Qualifications: University degree in a scientific field and 2 years' experience in regulatory affairs or quality.
- Other info: Diversity is celebrated here; all backgrounds are encouraged to apply.
The predicted salary is between 28800 - 43200 £ per year.
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- Shall implement and work to all applicable regulatory and quality requirements
- Shall implement and work to all applicable Health, Safety and Environmental requirements
- Generate and maintain technical documentation for compliance to applicable regulations
- Initiate change requests to update IFU and labelling of the OKM portfolio
- Review product and/or process change requests
- Support regulatory compliance projects e.g., EU MDR and NPD/sustaining projects
- Drive process updates and contribute to process improvement
- Have ownership of change management within product design
- University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering or similar discipline
- Minimum 2 years’ experience in regulatory affairs, quality or R&D in the medical device industry
- Good understanding of the regulatory framework applicable to medical devices
- Change management experience is essential for this role, specifically the ownership from start to finish of a product design change
- Excellent communication and negotiation skills
- Good organisational skills
- Ability to work in a team
- Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point).
- Patient Focus – We put patients at the heart of everything
- Integrity – We do the right thing
- Innovation – We look for new ways to make things better
- Impact – We take accountability and get things done
- Empathy – We care for one another and work together
- In addition to a competitive salary, you will receive a generous annual leave entitlement
- You will be eligible to receive private medical cover
- Comprehensive company pension scheme
- You will receive an annual health check with BUPA, funded by us
- Employee Assistance Program to support your health, mental and emotional-wellbeing
- At our HQ, we have a subsidised staff restaurant and free parking
- Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers
Your Responsibilities
- Shall implement and work to all applicable regulatory and quality requirements
- Shall implement and work to all applicable Health, Safety and Environmental requirements
- Generate and maintain technical documentation for compliance to applicable regulations
- Initiate change requests to update IFU and labelling of the OKM portfolio
- Review product and/or process change requests
- Support regulatory compliance projects e.g., EU MDR and NPD/sustaining projects
- Drive process updates and contribute to process improvement
- Have ownership of change management within product design
Your qualification
- University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering or similar discipline
- Minimum 2 years’ experience in regulatory affairs, quality or R&D in the medical device industry
- Good understanding of the regulatory framework applicable to medical devices
- Change management experience is essential for this role, specifically the ownership from start to finish of a product design change
- Excellent communication and negotiation skills
- Good organisational skills
- Ability to work in a team
- Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point).
Your competencies
- Patient Focus – We put patients at the heart of everything
- Integrity – We do the right thing
- Innovation – We look for new ways to make things better
- Impact – We take accountability and get things done
- Empathy – We care for one another and work together
Your Benefits
- In addition to a competitive salary, you will receive a generous annual leave entitlement
- You will be eligible to receive private medical cover
- Comprehensive company pension scheme
- You will receive an annual health check with BUPA, funded by us
- Employee Assistance Program to support your health, mental and emotional-wellbeing
- At our HQ, we have a subsidised staff restaurant and free parking
- Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers
Further Information
Valuing diverse perspectives and lifestyles is closely aligned with our core values. We would therefore like to encourage all candidates to apply – regardless of gender, nationality, ethnic and social origin, religion, age, disability, sexual orientation, marital status, identity or conditions and restrictions which cannot be shown.
Seniority level
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Seniority level
Entry level
Employment type
-
Employment type
Full-time
Job function
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Job function
Legal
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Industries
Medical Equipment Manufacturing
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Regulatory Affairs Specialist employer: Olympus Corporation
Contact Detail:
Olympus Corporation 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, especially the EU MDR. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in regulatory affairs through platforms like LinkedIn. Engaging with industry groups can provide insights into the role and may even lead to referrals, increasing your chances of landing an interview.
✨Tip Number 3
Prepare to discuss specific examples of your change management experience. Be ready to explain how you've successfully managed product design changes from start to finish, as this is a key requirement for the role.
✨Tip Number 4
Showcase your communication and negotiation skills during any interactions with the company. Whether it's in a phone call or an informal chat, demonstrating these abilities can set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, quality, or R&D within the medical device industry. Emphasise your understanding of the regulatory framework and any change management experience you have.
Craft a Strong Cover Letter: In your cover letter, express your passion for patient focus and innovation. Mention specific examples of how you've contributed to regulatory compliance projects or process improvements in previous roles.
Highlight Key Skills: Clearly outline your excellent communication, negotiation, and organisational skills. Provide examples of how you've worked effectively in a team and used IT skills in MS Office to support your work.
Showcase Your Qualifications: Include details about your university degree in a scientific subject and any additional certifications related to regulatory affairs. This will help demonstrate your qualifications for the role at Olympus Corporation.
How to prepare for a job interview at Olympus Corporation
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks applicable to medical devices. Be prepared to discuss specific regulations like EU MDR and how they impact product design and compliance.
✨Showcase Change Management Experience
Highlight your experience in change management, especially your role in overseeing product design changes from start to finish. Be ready to provide examples of how you've successfully managed these processes in previous roles.
✨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 cross-functional teams in past projects.
✨Emphasise Teamwork and Organisational Skills
Be ready to talk about your ability to work in a team and your organisational skills. Share examples of how you've collaborated with others to achieve regulatory compliance or improve processes in your previous positions.