Regulatory Affairs Specialist
KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Chief Quality Officer
Type of employment: Permanent employment
Function: Quality / Audit / Corporate Governance
Location: Southend-on-Sea, England, United Kingdom
As a Regulatory Affairs Specialist, you will be responsible for executing international product registrations for medical devices and associated products, according to the individual country's specific requirements. Working as a part of a small yet dedicated team, your role will directly support our manufacturing organisation.
Your responsibilities
* Generating and maintaining technical documentation for compliance to applicable regulations
* Initiating change requests to update IFU and labelling of product portfolio
* Review product and process change requests
* Support regulatory compliance projects as required e.g., EU MDR and new product development/sustaining projects
* Drive process updates and contribute to process improvements
Qualifications
* University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering or similar discipline
* Demonstrable experience in regulatory affairs, quality assurance or R&D in the medical device industry
* Possess a good understanding of the regulatory framework applicable to medical devices
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
Benefits
* Competitive salary
* Generous annual leave entitlement
* Private medical cover
* Comprehensive company pension scheme
* Annual health check with BUPA, funded by us
* Employee Assistance Program to support your health, mental and emotional well-being
* Subsidised staff restaurant and free parking at HQ
* 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 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.
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