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 rapid-paced workplace. This role offers the prospect to make a significant impact on the success of our clients and contribute to the growth of our consultancy firm.
Job Description
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 Knowledge