Regulatory Affairs Manager

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 around 10,000 colleagues, we provide our products and services in almost 100 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. Group revenues in 2023 were over $2 billion.

The company is a constituent of the FTSE 100 Index (LSE: CTEC). To learn more about Convatec, please visit http: //www. convatecgroup. comPosition Overview: The RA Manager will be collaborating with your counterparts globally to work on regulatory and Quality Assurance initiatives and supports hybrid work. You will be supporting markets in multiple time zones and some flexibility around working hours will be needed. Key Responsibilities:

Develop regulatory strategy and update the strategy based upon regulatory changes and business needsManage and execute regulatory compliance activities as required by the local regulationsCompile, 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 launchMonitor and submit applicable reports and appropriate responses to the local health authoritiesReview 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 requirementsInteract with local health authorities during review process to ensure timely regulatory approvalEnsure compliance with product post marketing approval conditionsManage 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 ConvaTec standards and procedures as well as the local regulationsSupport and/or participate as necessary in quality compliance auditsMaintain the organization and security for all regulatory paper and electronic filesProvide support in product safety issues and product associated events and responsible for reporting to the local health authoritiesAs 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 labellingPrepare and submit all reporting activities associated with a removal or correction with the local health authorities and ConvaTec Global Compliance TeamMaintain 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 applicationsCommunicate regulatory issues that may impact the marketing of the products to internal stakeholdersWork in close collaboration with key functions such as supply chain, marketing and country manager for regulatory project / change implementationMay be tasked to act as the company focal point for interaction with various government agencies in response to queries from the agenciesTo be successful in this role you will have: 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 necessaryRelated experience and knowledge in regulatory submissions to local authority requiredRelated experience and knowledge in Quality Management System, including but not limited to recalls, correction and labeling requirements is advantageousExperience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 is advantageousOur ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging.

But, as the progress you make will help improve the lives of millions, it’ll be worth it. This is stepping up to a challenge. This is work that’ll move youBeware of scams online or from individuals claiming to represent ConvatecA 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 RepresentativesConvatec 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!