RA/QA Manager
RA/QA Manager
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Job Description
With more than 10000 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
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You will lead the regulatory activities for all Convatec products including product registration (new renewal and amendment) product promotional activities labeling review activities product registration and listing database.
Location: Gurgaon
Key duties 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
Interact with the local health authorities in during the review process to ensure timely regulatory approval
Ensure 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.
Maintain the organization and the security for all regulatory paper and electronic files.
Manage 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.
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.
Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities.
Review approve/disapprove product labeling advertising and promotional request field communications etc.
Prepare and submit all reporting activities associated with a removal or correction with the local health authorities
Maintain and timely update new product listings 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.
Act as the company focal point for interaction with various government agencies in response to queries from the agencies.
Skills & experience
Bachelors degree in science or relevant field
Minimum of at least 3 5 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 advantageous.
Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 is advantageous.
At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.
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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.
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!
Required Experience:
Manager
Employment Type
Full-Time
