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1+ months

Post-market Regulatory Supervisor

Medtronic
Canberra, ACT 2617
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Post-market Regulatory Supervisor

Location:

Macquarie Park, New South Wales, Australia

Requisition #:

20000L3I

Post Date:

Dec 14, 2020


**Careers That Change Lives**


Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.


The Post-market Regulatory Supervisor is a leader in the Quality Regulatory Team, ensuring compliance of Medical Devices marketed by Medtronic Australasia with Post Market requirements in line with Australia and New Zealand Medical Device Regulations.


Reporting to the Senior Quality Systems Post-market Vigilance Manager, the Post-market Regulatory Supervisor is an experienced Quality / Post-market Vigilance (PMV) professional, who will lead the PMV Team and be responsible for the operation, monitoring and success of all PMV processes. The Post-market Regulatory Supervisor is also the primary escalation contact with the TGA Medsafe on Medtronic PMV activities.


This role also requires excellent communication and collaboration with internal commercial and functional stakeholders around the globe to ensure effective post-market management of all Medtronic products in Australia New Zealand. The future direction of the role will also include an external customer element and commercial exposure.


**A Day in the Life**


**In this role, you will:**


+ Provide day-to-day work direction for team, providing tactical and technical leadership, along with coaching and development.

+ Perform individual tasks as required in support of following team process responsibilities across all Medtronic Operating Units:

+ oversight of product complaint processes

+ internal quality holds

+ execution of field corrective actions

+ adverse event reporting and regulator inquiries

+ Ensure effective stakeholder engagement with regulators, customers, internal commercial and functional leaders.

+ Process data monitoring and analysis as input to continuous improvement activities.

+ Performs duties in compliance with Quality System, environmental, health and safety related site rules, policies or governmental regulations.


**Must Have Minimum Requirements**


+ A Bachelors degree in Engineering or Science related disciplines, is essential

+ Solid background in a Quality or Regulatory role within the healthcare industry, with experience in post-market obligations for therapeutic products, preferably in medical devices

+ At least 3 years of experience working with regulatory bodies TGA and Medsafe

+ Sound working knowledge of Quality Management System principles, and experience working within Healthcare / Lifesciences (ISO 9001, ISO 13485 or similar)

+ People management experience with strong leadership capabilities and proven success in leading and developing teams

+ A confident, highly effective communicator with proven ability to collaborate cross-functionally and influence both internal and external stakeholders

+ Strong aptitude for learning, interpreting and communicating technical concepts coupled with good analytical thinking and problem-solving skills


**_Please note there will be a delay in the review of applications received over the Christmas New Year period as we break for the holiday season._**


**_We appreciate your patience and will be in touch as soon as possible after this time._**


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can accelerate and advance our ability to create meaningful innovations but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-12-24 Expires: 2021-03-26
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Post-market Regulatory Supervisor

Medtronic
Canberra, ACT 2617

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