Mayur Ghangale
Regulatory Affairs Specialist
- Role
- Regulatory Affairs Specialist at Philips
- Location
- Vasai Virar, MH, IN
- LinkedIn followers
- 500 followers
About Mayur Ghangale
Skilled in Regulatory Affairs and Quality Management of Medical Devices (MD) and Personal…
Experience
Regulatory Affairs Specialist
Oct 2023 — Present · Pune, IN
Compile and review the necessary local and in-country documentation for relevant stakeholders to complete registration activities- Ensure the technical files and documentation are up-to-date through periodic review- Generate various technical documentation and declarations of conformity- Review country specific submission packages and technical documents as per requirements set out by health authorities- Keeping data up-to-date in the system by providing information entry into regulatory databases, submission software programs (Rimsys, Windchill, Agile, Regdesk, and Share Drive), and creating reports as required- Preparing and maintaining product registration files to keep marketing approval and import licenses per local regulatory requirements for CE-marked or FDA-cleared devices by making sure products comply with the regulations- Ensure completion of the International Registration Schedule and report progress per established KPIs to introduce new products and keep continuous product access to the markets- Preparing regulatory filings for new products, as well as significant post-market changes- Manage record retention (licenses and submissions) per company policy- Product Life cycle management- Implementation of global regulatory strategy and road maps through understanding the competitive market landscape and product marketing strategy- Identifying process optimization to strengthen the International Regulatory Department and implement required improvements- Providing accurate and consistent regulatory recommendations, decisions, and feedback to RA stakeholders- Experience in multiple types of international regulatory submissions- Excel automation and Power BI expertise for data visualization and planning.
Skills
- Microsoft Office
- Customer Service
- Microsoft Excel
- Management
- Microsoft Word
- Powerpoint
- Public Speaking
- Research
- Project Management
- Leadership
- Physical Education
- Karate Trainer
- Event Planning
- Strategic Planning
- Java
- C
- C++
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