Role: Senior Regulatory Manager level role ( PERM )
Location: Southampton area - Financial relocation assistance on offer
Salary- ( on application ) Excellent package
Job Summary
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.
Essential Functions & Accountabilities
Regulatory Strategy and Leadership:
- 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:
- 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:
- 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:
- 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:
- 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.
Travel Requirements
Up to 20% local or international travel to facilities, government agencies, customers, trade shows, or training courses.
Qualifications
Knowledge, Skills, and Abilities
- 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.
Experience
- 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.
Education
Bachelor’s degree in a scientific or technical discipline required. Advanced degree and Regulatory Affairs Certification highly desirable.
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