Regulatory manager

Key Responsibilities:

• Prepare and submit regulatory submissions, including product registrations, variations, renewals, and licenses to various Authorities in different countries.
• Prepare complete Documentation required for getting product registrations/notifications in different countries across the globe.
• Apply and manage CDSCO licenses for our medical devices to ensure compliance with Indian regulatory requirements.
• Ensure that our products meet all regulatory requirements for domestic and international markets.
• Ensure all certifications are upto date and responsible for renewing them before expiry.
• Develop, review, and maintain regulatory documentation, including technical files, product dossiers, and compliance reports to regulatory authorities. (e.g., 510(k), PMA, CE Marking)
• Support the preparation and review of labelling, packaging, and promotional materials to ensure they meet regulatory standards.
• Prepare, review, and submit regulatory documentation and applications (e.g., 510(k), PMA, CE Marking) to regulatory authorities.

Mandatory Requirements

Should have experience in acquiring Product registrations from different countries 

• Hands-on experience preparing and submitting regulatory documentation, such as 510(k), PMA, CE Marking applications, and other relevant filings.
• Must have knowledge of class 3&4 Medical devices 

Key Skills

• Excellent written and verbal communication skills, with the ability to produce high-quality documentation and reports.
• Demonstrated ability to manage multiple projects simultaneously and work under tight deadlines.
• Strong organizational skills and attention to detail.

Required Educational Qualification:

• Bachelor’s Degree: In a relevant field such as Life Sciences, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
• Advanced Degree (Optional but Beneficial): Master’s degree or PhD in Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field.

Why Join Us:

• Travel Opportunities (Domestic and International)
• Attractive Incentives
• Competitive Salary
• Job Security
• Complimentary Lunch: Enjoy a free lunch provided everyday by the company.
• Appreciation Rewards: Receive thank-you gifts for your dedication, including a car upon completing six years with us.