Regulatory Affairs Specialist

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.