Walk-in | Assistant Manager - Regulatory Affairs

Polymed; Faridabad District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Polymed India is seeking a proactive Regulatory Affairs professional to ensure medical devices comply with global and regional regulations. You will prepare technical documentation and navigate MDR, FDA, and ISO standards across the product lifecycle.

You will monitor regulatory changes, coordinate with R&D, Quality and Manufacturing, manage submissions (FDA 510(k), CE, Health Canada), and lead post-market surveillance activities including PSURs and PMCF plans.

Qualifications

• Experience ensuring compliance with global and regional medical device regulations.
• Familiarity with ISO 13485, MDR, FDA 510(k) and post-market surveillance.
• Ability to prepare and maintain technical documentation and filing dossiers.

Responsibilities

• Ensure products comply with global, regional, and national regulatory requirements (FDA, EU MDR, ISO 13485, MDSAP).
• Prepare and maintain Technical Documentation per EU MDR Annexes II and III.
• Monitor regulatory changes and implement updates across portfolio.
• Coordinate with R&D, Quality, and Manufacturing to ensure regulatory compliance across lifecycle.
• Manage submissions and maintenance of regulatory dossiers (FDA 510(k), CE, Health Canada).
• Develop Post-Market Surveillance plans and PSURs for Class IIa/IIb/III devices and PMCF.
• Create regulatory strategies for new product development and ensure design inputs meet compliance.
• Provide regulatory guidance during lifecycle management including changes and labeling.
• Address audit findings and ensure CAPA effectiveness.
• Review marketing materials for regulatory alignment.
• Maintain records of regulatory submissions and authority communications.
• Manage lifecycle of regulatory documents for audits and inspections.
• Assess impact of regulatory changes and communicate actions to senior management.
• Submit product/process/QMS changes to Notified Body per MDR change control.
• Review marketing claims to avoid non-compliant statements and ensure accuracy.
• Provide training on regulatory requirements to internal teams and stay updated.

Skills

Regulatory affairs

Documentation management

CAPA & GMP knowledge

Job description

Key Responsibilities :

• Ensure that all products comply with global, regional, and national regulatory requirements (e.g., FDA 21cfr part 820, EU MDR 2017/745, ISO 13485, MDSAP).
• Preparation and maintenance of Technical Documentation (Technical Files and Design Dossiers) in accordance with Annexes II and III of the EU MDR.
• Monitor changes in regulations, standards, and guidelines relevant to the companys product portfolio, ensuring timely implementation of necessary updates.
• Coordinate with internal teams (e.g., R&D, Quality, and Manufacturing) to ensure products are developed, manufactured, and distributed in compliance with applicable regulations.
• Oversee and manage the submission and maintenance of regulatory dossiers for product registrations, renewals, and variations (e.g., FDA 510(k), EU Technical Files, CE marking, Health Canada licenses etc).
• Develop and manage the Post-Market Surveillance (PMS) system, including the preparation of Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices and Post-Market Clinical Follow-up (PMCF) plans and reports.
• Develop and implement regulatory strategies for new product development, ensuring that regulatory requirements are integrated into product design and development processes.
• Provide regulatory guidance during product lifecycle management, including design changes, manufacturing changes, and labelling updates.
• Address and close any non-conformities raised during any inspections or regulatory audits, ensuring corrective and preventive actions (CAPA) are implemented effectively and efficiently.
• Review and approve product labelling, advertising, and promotional materials to ensure compliance with regulatory requirements.
• Maintain records of all regulatory submissions, communications with authorities, and approvals for internal audits and compliance purposes.
• Manage the lifecycle of regulatory documentation, ensuring that all documents are accurate and retrievable for audits or inspections.
• Evaluate the impact of regulatory changes on the company's products and operations and communicate necessary actions to senior.
• Ensure that any product changes, process changes, or QMS changes are thoroughly evaluated and submitted to the Notified Body when required, per MDR’s change control requirements.
• Review and approve marketing and promotional materials to ensure alignment with the EU MDR and avoid non-compliant claims.
• Provide regulatory training to internal teams to ensure understanding and compliance with regulatory requirements.
• Stay up to date with global regulatory trends, guidance documents, and best practices, ensuring the company remains proactive in its approach to compliance.