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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and leading Medical Affairs strategies, establishing governance frameworks, and managing cross-functional collaborations in regulated environments. Possesses strong knowledge of medical safety, evidence generation, and regulatory requirements relevant to diagnostics and medical devices.
Highest-signal resume keywords
Medical Affairs Strategy DevelopmentRegulatory Compliance KnowledgeKOL Engagement and ManagementEvidence Generation and Investigator-Initiated StudiesScientific Communication and Writing
About the role
Key responsibilities & impact- Establish and lead a scalable, high-performing Medical Affairs capability
- Develop Medical Affairs strategies for priority products, disease areas and clinical applications
- Identify clinical unmet needs, evidence gaps, barriers to clinical adoption and Medical Affairs priorities
- Capture and communicate medical and scientific insights to R&D, Product, Clinical, Regulatory and Commercial teams
- Establish Medical Affairs operating models, governance, processes, documentation standards, systems and metrics
- Develop an integrated medical evidence-generation pipeline
- Establish and govern a global Investigator-Initiated Studies programme
- Develop KOL and external expert management frameworks and scientific advisory board governance
- Establish medical safety and medical review capabilities for regulated IVD products
- Provide medical expertise for complaint escalation, safety signals, clinical harm, vigilance and risk management
- Establish frameworks for Laboratory Developed Tests in the United States and in-house devices/tests under the EU IVDR
- Partner with R&D, Product, Clinical and Regulatory Affairs throughout new product development and lifecycle management
- Develop medical and scientific training for Commercial and customer-facing teams
- Review scientific and educational materials for accuracy, balance and regulatory consistency
- Partner with Commercial teams while maintaining Medical Affairs independence and scientific integrity
Requirements
What you’ll need- An advanced degree in medicine, life sciences or a related discipline, or equivalent experience
- Significant Medical Affairs experience within the diagnostics, medical device, life sciences or pharmaceutical industry
- Demonstrated experience establishing or leading Medical Affairs programmes and working cross-functionally in regulated environments
- Demonstrated experience developing medical strategies and translating clinical and scientific needs into executable Medical Affairs plans
- Experience across several of: evidence generation, investigator-initiated studies, KOL engagement, advisory boards, scientific exchange, medical education, medical governance, medical safety and product lifecycle support
- Experience within molecular diagnostics, genomics, sequencing, precision medicine or other complex diagnostic technologies is highly desirable
- Strong working knowledge of regulated product development and lifecycle requirements relevant to diagnostics, including ISO 13485, ISO 14971, FDA IVD requirements, applicable 21 CFR requirements and EU IVDR
- Understanding of clinical/performance evidence, post-market surveillance and vigilance requirements
- Excellent scientific communication and writing skills
- Pragmatic problem solver and effective senior cross-functional leader
- Ability to prioritise competing requirements, influence without direct authority and make sound decisions where information may be incomplete
Benefits
Comp & perks- Permanent employment
- Hybrid working arrangement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Affairs Programme LeadershipEvidence GenerationMedical SafetyClinical Needs AssessmentRegulatory Requirements KnowledgeISO 13485ISO 14971FDA IVD RequirementsEU IVDRMolecular Diagnostics
Soft Skills
Pragmatic Problem SolverEffective Cross-Functional LeadershipInfluencing Without AuthorityDecision-MakingPrioritization
Industry Keywords
DiagnosticsMedical DeviceLife SciencesPharmaceuticalClinical AdoptionScientific Advisory BoardsPost-Market SurveillanceVigilance RequirementsPrecision MedicineGenomics