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Description
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 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 http://www.convatecgroup.com
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.
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 bachelor’s degree in Science, Engineering, Medical Technology, or Nurse required.
An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.
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, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
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.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!
Regulatory Affairs Specialist (AWC) | Convatec | Hunt UK Visa Sponsors
