Job Description

Careers that Change Lives

Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met. Responsible for coordination with other Geographies for International Regulatory Submissions, License Renewals and annual registrations

A Day in the Life

Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.

Must Have

Job Responsibilities

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.

Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.

Compiles all materials required in submissions, license renewal and annual registrations

Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance

Monitors and improves tracking/control systems

Keeps abreast of regulatory procedures and changes.

May direct interaction with regulatory agencies on defined matters.

Recommends strategies for earliest possible approvals of clinical trials applications.

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.

Minimum Qualifications

Bachelor\xe2\x80\x99s degree in Medical, Mechanical, Electric Life Science or other healthcare related majors

7+ years experiences for RA role in medical device and or pharmaceutical industry

Works independently with general supervision on larger, moderately complex projects / assignments.

Contributes to the completion of project milestones.

Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making

Nice to Haves

Excellent communication and interpersonal skills

Excellent written, organizational, and communication skills is required, and have a flexible and team oriented attitude.

Self motivated and positive

Ability to quickly establish credibility with all levels of customer base

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 lives.Help us shape the future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

Additional Information

• Posting Date: Jan 17, 2024
• Travel: No

Medtronic