Associate I, Regulatory Submissions

1 day ago


Pune, India Labcorp Full time

Implement use of consistent, efficient and quality processes to meet timelines and deliverables according to regulatory requirements

Ensure compliance of operations with governing regulatory requirements

Maintain a culture of high customer service

Prepare, compile & review Regulatory/Quality documents to support submissions to various markets

Coordinate and interact with other applicable client departments to discuss and provide solutions and sort issues

Seek guidance from other team members and manager as needed, and enhance report writing skills, adapt to other project requirements such as IAL, STL report generation, report automation etc.

Perform additional duties as assigned by the manager

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.


  • Regulatory Analyst

    1 week ago


    Pune, Maharashtra, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing...


  • Pune, Maharashtra, India Fortrea Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Job Overview:Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.Summary of Responsibilities:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • Pune, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...