Medical Affairs Lead for Clinical Development & Safety

Position Overview: This position of Clinical Lead is a senior individual contributor role within Medical Affairs, supporting the Continence Care, Infusion Care and Ostomy Care franchises. The role provides subject matter expertise across product safety, health hazard evaluation (HHE), complaint handling, post‑market surveillance, regulatory and clinical evidence activities, and partners closely with the Clinical Development Manager and cross‑functional stakeholders. The role leads complex workstreams, provides technical coaching to lower‑level professionals, and contributes to high‑quality, compliant deliverables without direct line management responsibility.

Key Responsibilities:

• Provides subject matter expertise and review for medical writing documents (e.g. CEP, CER, PMCF, PMS and PMCF‑related reports, publications, protocols and literature reviews).
• Supports regulatory submissions, registrations and agency/notified body inquiries, including EU device registration activities and US 510(k) submissions.
• Supports complaint investigations, medical safety assessments, HHEs, risk assessments and other patient safety/harm management activities for pre‑market and post‑market products.
• Provides medical and scientific input to post‑market surveillance activities, including trend review, signal assessment, benefit‑risk evaluation and escalation of emerging safety issues.
• Responds to medical information requests and off‑label questions and provides medical input to content review (MRL) and product claims substantiation.
• Provides input to pre‑clinical studies, usability and human factors activities, and the NPD/IDEAL process.
• Supports development and maintenance of Clinical Evidence Plans in partnership with Global Clinical Strategy, Regulatory Affairs and Clinical Affairs.
• Provides Medical Affairs input to endpoint development, study objectives, protocol review and safety oversight of clinical studies, and may support Medical Monitor activities as applicable.
• Works cross‑functionally with Regulatory Affairs, Quality, R&D, Legal, Marketing and Clinical Affairs to ensure scientifically robust and compliant deliverables.
• Leads large or complex projects and processes with limited oversight, manages competing priorities and delivers to timelines.
• Coaches, reviews and delegates work to lower‑level professionals as an experienced SME, without formal people management responsibility.

Skills & Experience:

• 5+ years of relevant medical device, medical affairs or clinical development experience, including pre‑market and post‑market activities.
• Strong understanding of clinical research and the medical device lifecycle, including the protocol/project relationship and key milestones.
• Strong understanding of the medical device industry and associated clinical, regulatory, quality, pre‑clinical and post‑market requirements.
• Experience supporting product safety, complaints, HHEs, post‑market surveillance and risk management activities.
• Experience supporting regulatory and clinical evidence deliverables such as CER, CEP, PMCF and 510(k)-related documents.
• Demonstrated medical writing capability and experience in literature review, evidence appraisal and scientific communication.
• Strong written and verbal communication, editing and proofreading skills.
• Strong interpersonal skills and ability to build cross‑functional relationships at all levels, both internal and external.
• Ability to manage multiple complex projects in parallel, anticipate issues and develop pragmatic solutions.
• Strong business acumen and ability to work strategically and tactically.
• Experience in continence care and/or ostomy care products is preferred.
• Strong computer skills and a high level of proficiency in Microsoft Office.
• Works to a high standard and ensures compliance with MDR, ISO 14155, applicable FDA requirements and Convatec SOPs.

Qualifications / Education:

• Medical, Nursing, Science, Engineering or Pharmacy degree. An advanced degree is preferred.

Team: Works collaboratively with other Medical Affairs specialists, Medical Affairs Team Leaders, Managers and Directors. This position has no direct reports.

Travel Requirements: Position may involve occasional travel up to 10% of the time, mostly within Europe but US and other overseas travel may be expected and could include overnight stays.

Working Conditions: This role will predominantly be remote (working from home) with occasional travel where needed for team meetings/events.

Special Factors: Occasional weekend working may be required to support conference attendance and Medical Affairs events (advisory boards, symposia, educational events, etc).

Equal Opportunities: Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.