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Regulatory Manager

Regulatory Manager

ConfidentialDelhi, India
6 days ago
Job description

Company Name

NARULA EXPORTS

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Industry

Medical Equipment

Department

Regulatory Affairs

Designation

Regulatory Manager

Experience

7-10 years

Salary

8-11 Lakhs

Company Details

We trace our earliest roots to 1953, when UNISON NARULA GROUP started its business of medical supplies with a noble cause to serve the one community called Mankind. At Narula Exports, we understand the critical role of reliable and innovative medical equipment in patient care. With years of experience and expertise in the industry, we strive to deliver cutting-edge solutions that meet the evolving needs of healthcare institutions. Our thrust being on QUALITY, we take pride in our products and services. Being an ISO, WHO, GMP Certified Company and some of our products are CE marked. Every step of our process undergoes rigorous Quality checks to ensure you receive nothing but the best. We conduct our business with Honesty, Transparency and a strong sense of Responsibility towards our Customers, Employees and the Environment.

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.

    • Skills Required

    regulatory documentation, PMA, ce marking, Regulatory Submissions

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