Senior Regulatory Affairs Specialist

Responsibilities may include the following and other duties may be assigned:

Set up new process for entering new data - Regulatory Information Management System

Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes

Keeps abreast of regulatory procedures and changes.

Provide requested regulatory data and documents to support tenders

Keeps abreast of regulatory procedures and changes.

Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.

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

May direct interaction with regulatory agencies on defined matters.

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.

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.

Required knowledge and experience:

Bachelor s 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.

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

Ability to quickly establish credibility with all levels of customer base

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

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.

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 95, 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.

Learn more about our business, mission, and our commitment to diversity here