Covantec (RA/QA Manager)

Job Type: Full-time

Location: Gurgaon, Haryana

About Convatec

Convatec is a global medical products and technologies leader, dedicated to improving the lives of people with chronic conditions. With core specializations in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care, Convatec provides trusted solutions in more than 90 countries, supported by a team of 10,000+ colleagues and a strong commitment to the promise of being Forever Caring.

Key Highlights:

• 2024 revenues exceeded $2 billion

• Listed on the FTSE 100 Index (LSE: CTEC)

• Purpose-driven innovations focused on infection prevention, skin protection, improved clinical outcomes, and reduced healthcare costs

Learn more at the official website.

Position Overview

You will be responsible for leading regulatory activities for all Convatec products in India. This includes product registrations (new, renewal, amendments), labeling and promotional material review, regulatory databases, and compliance with local health authority requirements.

Key Responsibilities

Regulatory Strategy & Compliance

• Develop and update regulatory strategies in alignment with evolving regulations and business goals.

• Manage and execute regulatory compliance activities per local authority requirements.

• Ensure post-marketing compliance with conditions attached to product approvals.

Regulatory Submissions

• Prepare, compile, review, and submit regulatory dossiers to health authorities.

• Identify submission issues early to minimize impact on timelines or product launches.

• Coordinate with regulatory authorities throughout the review process to secure timely approvals.

Documentation & Reporting

• Maintain regulatory files (electronic & paper) with high accuracy and confidentiality.

• Monitor, prepare, and submit mandatory regulatory reports and responses.

• Manage lifecycle activities including renewals, listings, change notifications, etc.

• Maintain and update product registration and listing databases.

Labeling & Promotional Review

• Provide and validate content for local labeling as per regulatory approvals and guidelines.

• Review, approve, or disapprove product labeling, advertising materials, promotional content, and field communications.

Product Safety & Quality Compliance

• Support safety-related issues, incident reporting, and corrective/removal actions with local authorities.

• Participate in quality compliance audits as needed.

Internal Collaboration

• Communicate regulatory risks or issues that may impact product marketing.

• Act as the primary contact for government authorities.

• Support commercial teams with regulatory documents for tenders, reimbursements, and other requirements.

Required Qualifications & Experience

• Bachelor’s degree in Science or a relevant discipline

• 3–5 years of experience in regulatory affairs for medical devices

• Experience with regulatory submissions to local health authorities

• Knowledge of Quality Management Systems, recalls, corrections, and labeling requirements (preferred)

• Familiarity with GDPMDS and ISO 13485 standards (advantageous)

Why Join Convatec?

At Convatec, we continuously innovate to deliver trusted medical solutions. If you want to make a meaningful impact and contribute to improving patient lives, this is the opportunity to bring our Forever Caring mission to life.

Important Notices

Fraud Alert

Convatec never requests personal information or payment during recruitment.
Always ensure you are contacted by an official Convatec email address.
If unsure, email: careers@Convatec.com

Equal Employment Opportunity

Convatec is committed to providing equal opportunities to all applicants and employees, regardless of race, color, gender, nationality, disability, or other protected characteristics.

For Recruitment Agencies

Convatec does not accept unsolicited resumes. Any such submissions become company property without obligation of payment.

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