Regulatory Affairs Specialist; AWC

Seniority level

• Entry level

• Full-time

• Legal

• Medical Equipment Manufacturing

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:

CTEC). To learn more please visit

Convatec has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from 2027, alongside a significant expansion of our facilities in Boston.

An exciting future in Manchester – the new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting‑edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state‑of‑the‑art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions.

The primary responsibilities of the position are to ensure regulatory compliance of a defined group of Convatec products, drive regulatory processes and activities (such as regulatory strategy, product registration, change control, review of marketing materials, etc.) and continue to develop strong working relationships with internal and external customers. The person will be responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of new product development, product life cycle and changes to existing products.

• Advise on strategies and registration requirements for product development and marketed products.
• Write and submit regulatory dossiers (e.g., US FDA submissions, EU CE marking and UKCA Technical Documentation), and interface with authorities during the review process.
• Lead regulatory assessment and actions for changes to product and QMS processes.
• Ensure regulatory compliance to maintain market approvals.
• Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship.
• Provide regulatory support to enquiries from customers and authorities.
• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio.
• Review, interpret and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
• Support base business activities, such as Annual Reports, Supplements, Labeling reviews, UDI.
• Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures.
• Supports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems.
• Regulatory review and approval of documents supporting the QMS and product registrations.
• Participates as an active member of Industry, Regulatory or Scientific Committees, as appropriate.
• This…