Senior Regulatory Affairs Manager - Strategic leadership role- Medical Devices- Move to south coast

Role: Senior Regulatory Manager level role ( PERM )

Location: Southampton area - Financial relocation assistance on offer

Salary- ( on application ) Excellent package

The Senior Principal RA Specialist provides expert regulatory partnership and direction for products from concept to launch and post-market. This role involves leading the creation, development, and implementation of global/regional regulatory affairs procedures, ensuring compliance with regulatory requirements, and maintaining regulatory compliance status. The Senior Principal RA Specialist will also play a significant role in technical audits and regulatory intelligence processes.

Regulatory Strategy and Leadership:

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• Develop and execute regulatory strategies for assigned corporate projects.
  
• Provide expert regulatory guidance to project core teams and internal stakeholders.
  
• Lead the creation and implementation of regulatory affairs procedures for marketed products.
  
• Ensure compliance with global and regional regulatory requirements.
  

Registration Activity:

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• Review and approve regulatory documents for product registration in assigned markets.
  
• Maintain submission documents and agile databases to ensure prompt and accurate access to regulatory information.
  
• Coach and mentor junior team members on regulatory submissions.
  

Monitoring and Compliance:

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• Keep up-to-date with regional and national regulations, guidelines, and advisory documents.
  
• Communicate regulatory requirements and changes to management and business partners.
  
• Establish and leverage relationships with government, regulatory agencies, and trade associations.
  

Product Labelling and Support:

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• Review and approve product labelling and marketing materials.
  
• Support “Own Brand” and “Private label” customers and liaise with EU Competent Authorities.
  
• Provide input to Regulatory Affairs Impact Documents (RAIDS).
  

Commercial Partnerships:

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• Participate in Cluster and Country Leadership Teams.
  
• Collaborate with Global Packaging/Labelling Operations to ensure final product meets package labelling requirements for intended destinations.
  
• Interface with project team members to drive regulatory and corporate initiatives to completion.
  
• Oversee and communicate project status to key stakeholders throughout the business, including the legal manufacturer, QA, Global RA, R&D, and Commercial.
  
• Participate in project initiation discussions with Global Supply Chain and Global Packaging to ensure meeting business goals related to Europe/ACE.
  

Up to 20% local or international travel to facilities, government agencies, customers, trade shows, or training courses.

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• Strong leadership attributes and ability to influence decision-makers.
  
• In-depth understanding of ISO 13485, MDSAP, MDD, MDR, and other relevant regulations.
  
• Excellent attention to detail, organizational, and technical writing skills.
  
• Proficient in MS Office applications and relational database systems.
  
• Ability to work effectively in multinational/multicultural environments.
  
• Strong communication skills and ability to manage multiple priorities.
  

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• 8-12 years of experience in the regulated medical device industry.
  
• Extensive experience with regulatory submissions and technical documentation.
  
• Proven track record of managing complex regulatory projects and audits.
  
• Experience in electronic document management systems.
  

Bachelor’s degree in a scientific or technical discipline required. Advanced degree and Regulatory Affairs Certification highly desirable.