Regulatory Affairs Specialist

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 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE : CTEC).

To learn more about Convatec, please visit

Our APAC GBS supports a hybrid working approach. You will be supporting markets in multiple time zones and some flexibility around working hours will be needed.

You will be responsible for the Regulatory activities on all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database.

Countries to be manage includes Malaysia, Indonesia, and other South East Asia countries as assigned.

Specific responsibilities of the role include, but are not limited to :

Support in the development of regulatory strategy and update the strategy based upon regulatory changes and business needs.

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 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.

May interact with local health authorities during the review process to ensure timely regulatory approval.

Support / execute activities for compliance with product post marketing approval conditions.

Complete all training as required and maintain training plans, records, etc.

Support and / or participate as necessary in quality compliance audits.

Support / execute activities the organization and the security for all regulatory paper and electronic files.

Support / execute activities in product lifecycle maintenance such as product license renewal, listings, change control notifications, etc.

Review, comment and approve / disapprove change controls request that may affect the marketing of products.

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.

As required, provide support in product safety issues and product associated events and reporting to the local health authorities.

Support / execute activities pertaining to 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.

Review and approve / disapprove product labeling, advertising and promotional request, field communications, etc. in accordance with Convatec standards and procedures as well as the local regulations.

Maintain and update new product listings, product delisting, registration of new manufacturing sites, etc. into the relevant registration and listing databases. Provide support to commercial team in providing regulatory documents required for reimbursement and tender applications.

Keep abreast of new and updated regulatory requirements and communicate the changes to the relevant stakeholders according to appropriate process as necessary.

Work in close collaboration with key functions such as supply chain, marketing and country manager for regulatory project / change implementation.

May act as the company focal point for interaction with various government agencies and lead / coordinate efforts in responding to queries from the agencies.

To be successful you will have :

Degree in relevant fields

Minimum 3 years of experience in medical device regulatory affairs is required

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 preferred

Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 is preferred

Good internal and external communication skills

Our 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 you

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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.

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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.