Medical Affairs Lead for Clinical Development & Safety

📋 Description

• • Medical Affairs Lead for Clinical Development & Safety is a senior individual contributor role supporting Continence Care, Infusion Care, and Ostomy Care franchises within ConvaTec’s Medical Affairs function, providing critical subject matter expertise in product safety, regulatory compliance, and clinical evidence to ensure scientifically robust and compliant medical device lifecycle management.
• • Day-to-day responsibilities include reviewing medical writing documents (CEP, CER, PMCF, PMS), supporting regulatory submissions (EU device registration, US 510(k)), conducting complaint investigations and medical safety assessments (HHEs, risk assessments), providing input to post-market surveillance and benefit-risk evaluations, responding to medical information requests, contributing to pre-clinical studies and usability testing, supporting Clinical Evidence Plan development, and collaborating cross-functionally with Regulatory Affairs, Quality, R&D, Legal, Marketing, and Clinical Affairs to ensure deliverables meet MDR, ISO 14155, FDA, and internal SOP standards.
• • ConvaTec is a global medical products and technologies company with over 10,000 colleagues operating in ~90 countries, focused on chronic condition management through leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care; the company reported over $2 billion in revenue in 2024 and is a FTSE 100 constituent (LSE:CTEC), united by a promise to be forever caring through infection prevention, skin protection, improved patient outcomes, and reduced care costs.
• • The role offers the opportunity to lead complex workstreams with limited oversight, provide technical coaching to junior professionals without formal management responsibility, deepen expertise in medical device safety and regulatory affairs across pre- and post-market activities, and contribute to high-impact, compliant deliverables that support product safety and market access in key therapeutic areas.