Regulatory Affairs Specialist

1 week ago

Sydney, Australia Medtronic Full time

**Careers that Change Lives
**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. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Medtronic is seeking a highly skilled Regulatory Affairs Specialist to join the team in Sydney. Is this the next step in your career?

**A Day in the Life
**Responsibility**:

- Review, Prepare, compile and submit all documentations required for medical device registration including license renewal, new device registrations and change notification with relevant regulatory agencies (TGA and MEDSAFE)
- Manages and implements internal regulatory tracking / control systems.
- Keeps abreast of regulatory requirement and changes. Evaluate new requirement and provide business impact if any.
- Liaise with regulatory agencies on defined matters.
- Work closely with Global RA partners to obtain registration documents.
- Participate in monthly/bi-monthly/quarterly regulatory meeting with Global RA partners.
- Establish close interaction with local business team via monthly/bi-monthly/quarterly regulatory meeting.
- Anticipate regulatory obstacles and emerging issues throughout the device registration cycle. Provide solution or escalate if needed to overcome the issue.
- Support MDSAP audits for the products that you are responsible for
- Get involved in cross functional assignments.
- Reviews labelling to ensure proper process is in place if a local label is required.
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Any other related duties may be assigned from time to time.

**Must Have**
- Bachelor’s degree in science or related discipline.
- Preferred 2 to 3 years of Regulatory Affairs experience in the Medical Device industry in Australia.
- Good knowledge in Therapeutic Goods (Medical Device) Regulations 2002

**Nice to Have**
- Possess good communication skills and proficiency in English.
- Experience in cross functional working in a matrix organization is an added advantage.
- Can work independently with general supervision.
- Understanding of TGA requirements for System and Procedure Packs

**We Offer
**In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.

Also, a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:

- Flexible working environment; and great team environment
- Annual Incentive Plan % depending on company results;
- Healthcare insurance incentive
- Training opportunities via Cornerstone/Harvard Manage Monitor/GetAbstract
- Employee Assistance Program and Recognize (our global recognition program)

**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.

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