India Job Openings
Medtronic
Regulatory Affairs Specialist
FULL TIME
September 14, 2024
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.
- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
- Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.
- Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
- Develop Regulatory Strategies for new or modified products for assigned projects.
- Monitor and provide information pertaining to impact of changes in the regulatory environment.
- Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
- Document, consolidate, and maintain oral and written communication with health authorities
- Prepare internal documents for modifications to devices, when appropriate.
- Participate in health agency inspections & notified body audits as necessary.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
- Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
- Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
- Ensure compliance to regulations specific to clearance and approvals of MEIC developed product’s raw material and/or prototype.
- Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
- 4-7 years experiences for RA role in medical device and or pharmaceutical industry
- Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
-
Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure;
Good at English, including reading, writing, and speaking; - Good Learning attitude
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
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