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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs and medical device services, with a strong ability to lead project teams and manage client relationships effectively. Proficient in translating strategic goals into actionable plans while ensuring compliance with quality standards and regulatory requirements.
Highest-signal resume keywords
Regulatory Affairs ExpertiseMedical Device Services KnowledgeProject Management SkillsClient Relationship ManagementStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsMedical Device ServicesProject ManagementChange ManagementProblem SolvingBusiness DevelopmentTechnical DocumentationQuality ManagementMedical Advice SupportAnalytical Skills
Soft Skills
Relationship ManagementEffective CommunicationPresentation SkillsTeam CoordinationPrioritization
Industry Keywords
Medical TechnologyVeterinary ProductsHealth AuthoritiesClient PartnershipsOperational PoliciesKPI ManagementService SupportContinuous OptimizationStakeholder EngagementStrategic Planning
About the role
Key responsibilities & impact- Lead the planning and execution of client projects in line with agreed KPIs, timelines, budgets, and quality standards
- Coordinate project teams, including internal colleagues and qualified external partners, to ensure effective delivery
- Provide expert consultancy and practical guidance to clients and colleagues on Medical Device Services matters
- Participate in regulatory, technical, and quality management activities for medical device and diagnostics clients
- Prepare, review, and compile project documentation within MDS assignments
- Communicate with clients and Health Authorities
- Support scientific advice procedures and represent clients in interactions with Health Authorities
- Build and maintain client relationships and identify opportunities for increased service support
- Contribute knowledge and insight to project staffing proposals and delivery planning
- Maintain awareness of Medical Device Services intelligence and share insights with colleagues
- Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences
- Contribute to department expertise and best practices
- Support VDC strategy implementation and continuous optimization
- Comply with internal processes and contribute to their improvement
- Provide day-to-day operational support to colleagues
- Support commercial, marketing, and business development activities, including proposal input
- Oversee project delivery against budget and support resolution of invoicing queries
- Provide on-site regulatory support to GCS clients where agreed with the Head of VDC REG
- Undertake other reasonable duties aligned to the role and expertise
Requirements
What you’ll need- Proven, in-depth professional experience in regulatory affairs, medical device services, or a related specialist field
- Strong expertise in medical technology and veterinary products
- Demonstrated experience supporting medical advice activities; medical advice experience and skills are essential
- Extensive knowledge of the discipline and strong understanding of business and client needs
- Proven ability to solve complex problems and lead delivery within a specialist environment
- University degree in Science or Engineering
- Ability to translate strategic customer, partnership, or internal project goals into tactical plans and concrete milestones
- Strong ability to define and manage escalation processes appropriately
- Structured, analytical, systematic, and independent approach to work
- Ability to prioritize effectively and take action in line with operational policies and project requirements
- Experience leading complex project activities and providing guidance related to change management
- Ability to proactively identify up-selling and cross-selling opportunities
- Strong capability to identify, document, and help drive resolution of project and program issues
- Ability to lead project teams, coordinate work effectively, and align responsibilities to team strengths
- Strong relationship management skills with internal stakeholders and external clients, including engagement with client department heads
- Ability to align on mid-term goals and support the development of long-term client partnerships
- Excellent written and verbal communication skills
- Proven ability to communicate critical issues clearly and recommend appropriate cross-functional solutions to decision-makers
- Strong presentation skills and a confident, professional presence
- Business fluency in English and the relevant local language
Benefits
Comp & perks- Benefit offerings outside the US may vary by country and will be aligned to local market practice
- Equal employment opportunity and non-discriminatory recruiting, training, compensation, benefits, promotions, and transfers
- Reasonable accommodations during the employment process for individuals with disabilities