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Regulatory Affairs Specialist (ANZ)


Canberra, ACT 2617
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Job Details

Regulatory Affairs Specialist (ANZ)


Macquarie Park, New South Wales, Australia

Requisition #:


Post Date:

Dec 08, 2020

**Careers that Change Lives**

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

As a Regulatory Affairs Specialist, you will be responsible for the coordination of all regulatory activity in Australia and New Zealand, and ensuring all regulatory activities are consistent with local regulatory authorities and corporate requirements.

You will be working closely with key internal stakeholders at Medtronic to assist with the planning and preparation of regulatory submissions for Medtronic products within the assigned Business Units Cranial Spinal Technologies and Retail Business.

This position is an 11 months maternity leave contract reporting to the Regulatory Affairs Supervisor.

**A Day in the Life**

**In this role, you will:**

+ Preform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Compile all materials required in submissions, license renewal and annual registrations.

+ Monitor the progress of submissions through contact with regulatory bodies and keeping Business Units up to date with progress.

+ Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance as appropriate.

+ Monitor and improve tracking / control systems.

+ Keep abreast of regulatory procedures and changes to ensure compliance.

**Must Have Minimum Requirements**

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

+ Prior experience in Regulatory Affairs within the medical device industry

+ Highly effective interpersonal and communication skills with ability to build strong working relationships with internal and external stakeholders

+ Solid planning and organizational skills

+ Strong attention to detail

**_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.
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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