BL Lifesciences jobs: Assistant Manager- Regulatory Affairs

Assistant Manager- Regulatory Affairs Job Vacancies at BL Lifesciences

About the Company

BL Lifesciences Pvt Ltd

Welcome to BL Lifesciences, a dynamic and innovative player in the healthcare industry. Committed to excellence, we are seeking qualified professionals to join our team. Explore the opportunity to grow with us and contribute to cutting-edge advancements in the medical device sector.

Company Vacancies List

Current Vacancy:

Position Title: Assistant Manager- Regulatory Affairs
Company Name: BL Lifesciences Pvt Ltd
Location: Greater Noida

Qualification: Degree holder of Science / B Pharma / Biotech/ Bio Medical Engineering.

Experience: 3-5 Years’ Experience of Regulatory Affairs in Medical Devices

Job Description

As an Assistant Manager in Regulatory Affairs, you will play a crucial role in ensuring compliance with regulatory guidelines for medical devices. Here are some key responsibilities:

1. Documentation Management:
   • Submit and follow up on required documentation/information with concerned authorities.
2. MDR-2017 Guidelines:
   • Proficiently handle pre/post-market regulatory submissions for medical devices as per MDR-2017.
3. Audit/Inspection Preparation:
   • Ensure the creation of adequate documentation for audits/inspections.
4. Training and Liaison:
   • Conduct training within the organization on specific regulatory requirements.
   • Liaise with manufacturers for obtaining necessary documents for device submissions.
5. Regulatory Submissions:
   • Coordinate and respond to requests from regulatory agencies.
   • Ensure the timely upload of regulatory submission dossiers (New/Endorsement/Renewal/Change Note/Queries/Query Responses).
6. Certificates and Approvals:
   • Ensure registration certificates, approvals, and import licenses for medical devices.
7. Sales Support:
   • Support the Sales team by providing regulatory documents for tender submissions.
8. Compliance and Accreditation:
   • Maintain approval tracking documentation.
   • Ensure accreditation from USFDA, ISO, CE, BIS, and other national and international agencies.
9. Training and Compliance:
   • Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
10. Global Regulatory Input:
    • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
11. Communication Skills:
    • Good communication skills in English.

How to Apply

Interested candidates are invited to share their resumes at hrd@bllifesciences.com.