Regulatory Affairs Specialist

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.