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OS Consultancy is seeking a motivated and detail-oriented individual to join our team as a Regularity Affairs specialist. The ideal candidate will be responsible for ensuring compliance with all regulatory requirements related to our client's products.

Key responsibilities include conducting research on regulatory guidelines, preparing and submitting regulatory submissions, and maintaining documentation of all regulatory activities. The successful candidate will have strong communication skills, a solid understanding of regulatory processes, and the ability to work both independently and collaboratively in a fast-paced setting. This role offers the opportunity to make a significant impact on the success of our clients and contribute to the growth of our consultancy firm.

- Responsible for ensuring compliance with regulatory requirements for products in various markets

- Prepare and submit regulatory submissions to health authorities
- Review and analyze regulations to determine impact on products




- Collaborate with internal teams to support product development activities
- Maintain up-to-date knowledge of regulatory requirements
- Communicate with regulatory agencies to address any issues or inquiries
- Coordinate and support regulatory inspections and audits
- Provide regulatory guidance and support to cross-functional teams
- Monitor changes in regulations and update internal stakeholders
- Participate in industry associations and forums to stay current on regulatory trends.

Designation

Regularity Affairs

Key Skills

Documentation and Change ManagementDocumentation and Record KeepingDocumentation ManagementDocumentation SkillsMedical DocumentationRegulatory AffairsRegulatory ComplianceRegulatory Compliance OfficerRegulatory GuidelinesRegulatory KnowledgeRegulatory UpdatesRisk ManagementStandards and Regulations

Industry

Healthcare

Functional Area

Medical Devices Manufacturing

Employment Type

Full Time

Education

Bachelor Degree

Job Type

Work From Office

📌 Regularity Affairs (Mumbai Suburban)
🏢 Os Consultancy
📍 Mumbai Suburban