Regulatory Affairs Manager

About [Employer hidden]

[Employer hidden] 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. [Employer hidden]’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

Our search for better is changing the lives of our patients. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We're looking for a motivated and passionate individual to join our team as Regulatory Affairs Manager , to have real impact and bring Forever Caring to life.

About Role

In this role, you'll play a key part in working alongside a dynamic team that values innovation, collaboration, and continuous growth.

Your key responsibilities will include:

• Develop regulatory strategy and update the strategy based upon regulatory changes and business needs
• Manage and execute regulatory compliance activities as required by the local regulations
• Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch
• Monitor and submit applicable reports and appropriate responses to the local health authorities
• Review and manage the development, writing, implementation and maintenance of appropriate procedures, templates, metrics, and databases related to regulatory activities and documentation in compliance with the local regulatory requirements
• Interact with local health authorities during review process to ensure timely regulatory approval
• Ensure compliance with product post marketing approval conditions
• Manage product lifecycle maintenance such as product license renewal, listings, change control notifications, etc.
• Complete all training as required and maintain training plans, records, etc.
• Review product labeling for approval in advertising and promotional request, field communications, etc. in accordance with [Employer hidden] standards and procedures as well as the local regulations
• Support and/or participate as necessary in quality compliance audits
• Maintain the organization and security for all regulatory paper and electronic files
• Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities
• As appropriate, provide content for local labelling in accordance with local regulation and registration approval and work with relevant parties to release and maintain the local labelling
• Prepare and submit all reporting activities associated with a removal or correction with the local health authorities and [Employer hidden] Global Compliance Team
• Maintain timely updates of new product listing, product delisting, registration of new manufacturing sites, etc. into the relevant registration and listing databases. Support to commercial team in providing regulatory documents required for reimbursement and tender applications
• Communicate regulatory issues that may impact the marketing of the products to internal stakeholders
• Work in close collaboration with key functions such as supply chain, marketing and country business unit managers for regulatory project / change implementation
• May be tasked to act as the company focal point for interaction with various government agencies in response to queries from the agencies

About You

To be successful you will:

• Bachelor/master's degree in science, Medical Technology or related disciplines. Regulatory Affairs Certification (RAC) is preferred.
• Minimum 5 years of experience in medical device regulatory affairs is necessary
• Related experience and knowledge in regulatory submissions to local authority required
• Related experience and knowledge in Quality Management System, including but not limited to recalls, correction and labeling requirements is advantageous
• Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 is advantageous

Education/Qualifications

• Minimum educational requirements if applicable (for example Degree, industry qualifications, etc)
• Industry memberships / Professional Registrations

What You’ll Get

At [Employer hidden] we believe in taking care of our people, because they’re the heart of everything we do. As part of our team, you’ll enjoy a range of benefits designed to support your wellbeing, growth, and success.

These include

• Flexible working arrangements,
• Ongoing learning and development opportunities
• Competitive remuneration
• Access to health and wellbeing programs

Ready to join us?

At [Employer hidden], 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.

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Equal opportunities

[Employer hidden] 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.

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