Regulatory Affairs Specialist
KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Corporate | Hybrid remote working
Type of employment: Permanent employment
Function: Quality / Audit / Corporate Governance
Location: Southend-on-Sea, England, United Kingdom
In this role, as a Regulatory Affairs Specialist, you will support change management. This will require collaboration with various functions e.g. R&D, Quality, and Manufacturing Engineering to manage sustaining changes in the medical device portfolio manufactured by Olympus in the UK & Ireland.
Your responsibilities
* Review and approval of change requests, representing Regulatory Affairs in weekly change boards to ensure appropriate regulatory action is taken during implementation of change.
* Engage with global counterparts to assess the impact of planned changes and notify them of implemented changes in a timely manner.
* Generate and maintain technical documentation for compliance with applicable regulations.
* Support regulatory compliance projects e.g., EU MDR and NPD/sustaining projects.
* Drive process updates and contribute to process improvement.
Minimum Requirements
* Prior experience in medical device Regulatory Affairs.
* University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering, or a similar discipline.
* Good understanding of the regulatory framework applicable to medical devices.
* Excellent communication and organizational skills.
* Ability to work with cross-functional teams and diverse cultures.
Core Values
* 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 that increases with your length of service. You will be eligible for private medical cover, a comprehensive company pension scheme, and an annual health check. At our HQ, we have a subsidized staff restaurant and free parking. Other benefits include flexible working hours, discounted gym membership, cashback and discounts, enhanced parental leave, and more!
About Olympus Corporate
The Corporate Division is responsible for centralized functions that include Finance and Controlling, HR, IT, Quality Management, and Supply Chain Management. It provides essential services and support to all business divisions and is an important project initiator and leader within the international network.
Further information:
Valuing diverse perspectives and lifestyles is one of our core values. We encourage all people 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.
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