Regulatory Affairs Manager

Key Responsibilities:

• Develop and execute global regulatory strategies for nephrology medical devices.
• Prepare, compile, and submit regulatory filings including 510(k), CE Technical Files, MDR submissions, and country-specific dossiers.
• Maintain up-to-date knowledge of relevant global regulations including FDA, EU MDR, ISO 13485, MDSAP, and local regulatory frameworks.
• Serve as a regulatory representative in cross-functional product development teams.
• Ensure regulatory compliance throughout the product lifecycle, including labeling, advertising, change control, and post-market surveillance.
• Act as primary contact for regulatory agencies during audits, inspections, and query responses.
• Develop and maintain Regulatory Intelligence specific to nephrology devices.
• Provide regulatory support for clinical trials, if required, including ethics committee submissions and clinical evaluation reports.
• Review and approve product labeling, IFUs, and promotional materials to ensure regulatory compliance.
• Lead internal regulatory audits and support third-party audits.
• Train cross-functional teams on regulatory policies and changes impacting the nephrology product portfolio.

Required Qualifications & Experience:

• Bachelor’s or master’s degree in pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• 7+ years of experience in Regulatory Affairs, specifically in the medical device industry.
• Strong experience in Class II / Class III medical devices, preferably with nephrology products.
• Proven track record of successful regulatory submissions in US, EU, and ROW markets.
• Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, and global regulatory requirements.
• Experience with regulatory software/tools and e-submissions is an advantage.

Skills & Competencies:

• Strong understanding of medical device development and regulatory pathways.
• Excellent written and verbal communication skills.
• Strong project management and leadership skills.
• Ability to work cross-functionally with R&D, QA, Clinical, and Marketing teams.
• High attention to detail, with strong organizational and documentation skills.
• Ability to influence regulatory strategy and decision-making.