Post: Regulatory Affairs Specialist-II
Job Description:
Responsible for implementing regulatory compliance systems and supporting Regulatory Affairs activities at Medtronic India. This role involves active participation in all activities related to the preparation, submission, and follow-up to obtain approvals/renewals for products, variations, line extensions, and labeling approvals of medical devices across various business units. The Regulatory Affairs Specialist-II will provide technical support by interpreting federal and local regulations as they apply to products, processes, practices, and procedures.
Key Responsibilities:
- Manage, plan, and execute the preparation, review, and submission of dossiers for product registrations, import licenses, and other approvals in compliance with regulatory requirements in India.
- Coordinate with global regulatory teams, local business units, and other functions to develop regulatory strategies and provide documentation support for submissions in India.
- Submit and track registration/re-registration applications with regulatory authorities.
- Liaise with product divisions to obtain relevant details for filing changes to approved products/licenses.
- Assess change controls through post-approval change management, ensuring regulatory compliance.
- Monitor changes in local and global regulations, communicate updates within the department, and adhere to SOPs/systems within the organization.
- Ensure business continuity through regulatory filings, approvals, and continuous regulatory compliance.
- Support Marketing Teams on Tender-related issues.
- Develop, implement, and maintain regulatory systems for document management within the department and organization.
- Interface and coordinate with regulatory agencies/competent authorities for submissions, registrations/licenses, amendments, compliance, packaging, and quality control testing.
Candidate Profile:
- B.Pharm/M.Pharm/Bachelor or Master’s Degree in Bio-Medical Engineering/Science discipline with training in Regulatory Affairs.
- 5-7 years of experience in the pharma/medical device/life science industry, with at least 2-3 years of medical device experience in regulatory affairs.
- Familiarity with various regulatory requirements for India regarding medical device registration, importclinical trials.
- Knowledge of CDSCO, FDA, CE, and other regulatory requirements, especially in Quality Systems and Design Control.
- Excellent communication and interpersonal skills.
- Customer-focused with the ability to establish credibility with all levels of regulatory agencies and government bodies.
- Self-motivated with a positive “Can do” attitude, capable of working autonomously and as a team player.
- Strong organizational and time-management skills.
Additional Information:
