Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
26-06-2025
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1 Vacancy
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Job Description
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OfficeJob Description
Responsibilities:
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market and for providing knowledgeable input to interdisciplinary the project teams and management.
- Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia ensuring timelines and standards are met.
- Support the implementation of regulatory activities at the LSG Indian plant ensuring compliance with QMS/GMP.
- Collaborate with R&D operations QA and product managers to meet regulatory and compliance requirements.
- Conduct regulatory investigations and analyses defining strategies and providing updates to cross-functional teams.
- Prepare and manage technical files/dossiers for regulatory products supporting global registration applications.
- Lead local performance evaluations tests and clinical studies to support product registration in India.
- Participate in Animal Health regulatory submissions and support the distributed team as needed.
- Coordinate post-market surveillance resolving technical complaints and implementing corrective actions.
- Review advertisement materials for compliance with MD/IVD regulations in South Asia.
- Analyze new and existing regulations preparing impact assessments for LSG projects.
- Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
- Participate in regulatory/quality audits exhibitions and conferences.
- Establish and maintain a network with consultants policymakers and regulatory agencies such as Indian CDSCO.
- Perform other tasks as assigned by the line manager.
Minimum Requirements:
Education and Qualifications:
- Bachelors degree or higher in Engineering Sciences or Medicine.
- Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices particularly with Indian CDSCO regulations.
Essential Skills and Abilities:
- Comprehensive understanding of regulations standards and guidelines for In-Vitro Diagnostic and Medical Devices especially in South Asia and Indian CDSCO regulations.
- Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
- Strong planning and organizational skills for regulatory submissions and project management.
- Excellent communication skills including written verbal and presentation abilities.
- Strong project management skills with the ability to lead regulatory projects.
- Strong analytical skills proactive and a resourceful problem solver.
- Ability to work effectively under pressure and manage flexible working hours.
- Comfortable with ambiguity and change providing clear mentorship in uncertain regulatory environments.
- Experience in leading compliance activities including post-market surveillance and advertisement review.
- Ability to establish and maintain a network with relevant consultants policymakers and regulatory agencies.
- Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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