Senior Regulatory Affairs Specialist- Q&R

About the jobAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Collaborate and partner with Design QA, RD, 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

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.

Responsibilities may include the following and other duties may be assigned

• 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.
  
  
  

Required Knowledge And Experience

• Bachelors 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
  
  
  

Physical Job Requirements

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.

Benefits Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

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 RD 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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