19 days old

Senior Regulatory Affairs Specialist

Medtronic
Canberra, ACT 2617
Senior Regulatory Affairs Specialist

Location:

Macquarie Park, New South Wales, Australia

Requisition #:

19000DHD

Post Date:

Jul 31, 2019


**Careers that ChangeLives**


Join an innovative team of subject matter experts whose
purpose is to support our customers beyond devices and be a part of a company
that thinks differently to solve problems, make progress, and deliver
meaningful innovations.


Medtronic are currently recruiting for an engaging and high
performing Senior Regulatory Affairs Specialist to join our Regulatory Affairs
Team.


**A Day in the Life**


Responsibilities include the following:


+ Provide leadership to a team of RA Specialists

+ Directs or performs coordination and preparationof document packages for regulatory submissions from all areas of company,internal audits and inspections.

+ Leads or compiles all materials required insubmissions, license renewal and annual registrations.

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

+ Monitors and improves tracking / controlsystems.

+ Keeps abreast of regulatory procedures andchanges.

+ May direct interaction with regulatory agencieson defined matters.

+ Recommends strategies for earliest possibleapprovals of applications.


**Must Have**


+ A seasoned Regulatory Affairs Specialist withleadership experience

+ Previous relevant experience in a Regulatoryrole, preferably in the Medical Devices or similar industry.

+ Demonstrated experience with the AustralianMedical Device Regulations and working knowledge EU Regulations

+ Experience in TGA Class III / AIMD applications

+ Computer literacy including sound knowledge ofthe MS Office suite of software.

+ High attention to detail and accuracy.

+ Willingness to learn and ability to managemultiple tasks.

+ Excellent communication skills with the abilityto liase at all levels


**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.


**.**
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.

Categories

Posted: 2019-08-06 Expires: 2019-09-08

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Senior Regulatory Affairs Specialist

Medtronic
Canberra, ACT 2617

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