About Us

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 http://www.convatecgroup.com.

 

Please note that this will be a 1-year contract role with potential conversion into permanent employment.

Roles and responsibilities:

• 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 ConvaTec 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 ConvaTec 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 manager 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

To 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 3 to 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

 

 

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 [email protected].

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!