Regulatory Affairs Specialist (AWC)

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: 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 10000 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. Convatecs 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 ofpioneering trusted medical solutions to improve the lives 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 companys 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 Manchesters vibrant life sciences ecosystem which includes leading universities hospitals and research institutions.

About the role:

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.

Key Responsibilities:

• 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
• 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 position serves as a delegate for the line manager stated on this job description

Authority:

Regulatory approval of required documentation to support product development registration and lifecycle management.

Skills & Experience:

• Preferred 1-2 years relevant experience preferably in a regulatory affairs role in the life science industry
• Understanding of the regulatory framework for medical devices.

• Understanding of the Quality System Regulations ISO 13485:2016 including preparation and
• implementation of standard operating procedures
• Experience with Class I II and III sterile medical devices.
• Preferred experience dealing directly with Notified Bodies Competent Authorities and/or the US FDA
• Experience with US/EU submissions preferred.
• Good time management and problem-solving skills.
• Strong interpersonal and collaborative skills.
• Ability to execute both reactively and proactively and in a timely manner.
• Ability to conduct thorough research of regulatory requirements and related issues to identify potential
• solutions and available options.
• Experience supporting change control and new product development projects
• Strong analytical skills with good judgment-making capabilities.
• Demonstrated organizational skills.
• Strong oral and written communication skills.
• Proficiency with Microsoft Office (Excel Word PowerPoint) Adobe Acrobat and Internet-based
• regulatory resources Trackwise Documentum etc.

Qualifications/Education:

• A minimum of a bachelors degree in Science Engineering Medical Technology or Nurse required.
• An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.

Principal Contacts & Purpose of Contact

Internal Marketing Operations Regional Regulatory Affairs R&D Quality Clinical Business-2-Business team

External Competent Authorities Notified Bodies other international government agencies and customers

Travel Requirements

Not more than 25% of work time.

There may be some business-related travel associated with this role dependent on project and / or local market and UK / US / EU travel associated with this role because some team members are home based and face-to-face contact with line manager and peers may be required.

Attendance of relevant training and development events would be required.

Some destinations may involve overnight stay(s).

Languages

• Speaking: English
• Writing/Reading: English

Working Conditions

This position is remote based with occasional travel to the office. The office location for this role is Deeside UK

Special Factors

There may be rare instances whereby an employee may be required to work outside of non-core hours/days. This may be due to an unexpected event crisis or project timeline pressure as may occur within the regulatory affairs industry.

Ready to join us At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.

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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.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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