Apac Regulatory Affairs Manager

4 days 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 Manager - Diabetes to join the team in Sydney with APAC scope. UIs this the next step in your career?

**A Day in The Life
**Responsibilities may include the following for the APAC region and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or 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.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.

**Must Haves**
- Bachelor's and minimum of 6 years relevant experience, or advanced degree with a minimum of 4 years prior relevant experience.
- Requires practical knowledge in leading and managing the execution of processes, projects and tactics within key APAC markets.
- Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.

**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;
- Annual Incentive Plan % depending on company results;
- Pension scheme and group discount on healthcare insurances
- Training possibilities 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.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Medtronic has been servicing Australia and New Zealand since 1973. We are a Best Place to Work in Australia and certified a Great Place to Work in both Australia and New Zealand. Medtronic was named by LinkedIn as a top company in Australia in 2021. We have also been recognized by the AFR on their ‘Most Innovative Companies List’ in 2019 and 2020.

  • Regulatory Affairs Manager

    6 days ago

    Sydney, Australia KE Select Full time

    Part of the Leadership Team at DiaSorin - Excellent opportunity to take the next step in your career - Stand alone role looking after ANZ with some APAC responsibilities **About The Company** KE Select have partnered exclusively with DiaSorin to uncover their next Regulatory Affairs Manager for ANZ. DisSorin is the global leader in the Molecular Diagnostics...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, Australia Lula Group Full time

    Hybrid working model - Highly-known company across APAC - Long term career progression **About the Company** Our client, a renowned Pharmaceutical company with a strong presence across the APAC region, is in the process of expanding its headquarters in Sydney. They are currently looking to add a skilled Regulatory Affairs Associate to their growing team....

  • Regulatory Affairs Manager

    1 week ago

    Sydney, Australia GWF Full time

    Amazing career development opportunities within the GWF business - Be a part of an iconic brand! - North Ryde based with flexible hybrid working options Tip Top is currently looking for a Regulatory Affairs Manager to be based in North Ryde, to lead the Regulatory Affairs function by partnering with relevant internal and external business stakeholders to...

  • Regulatory Affairs Specialist, Japac

    13 hours ago

    Sydney, Australia Masimo Full time

    Key Responsibilities - Prepare, submit, and manage regulatory filings for product registrations, renewals, and variations across JAPAC markets. - Monitor and interpret regional regulatory requirements to ensure ongoing product compliance and timely updates. - Collaborate with cross-functional teams (R&D, Quality, Marketing, and Commercial) to support product...

  • Regulatory Affairs Manager

    2 days ago

    Sydney, Australia PERSOLKELLY Full time

    If you are passionate about developing complementary medicines and nutritional supplements, this job is for you! **ABOUT THE ROLE**: PERSOLKELLY have an exciting opportunity for a Regulatory Affairs Manager to further their experience within the pharmaceutical industry. Our client is an established Pharmaceutical Manufacturer that specialises in...

  • Regulatory Affairs Manager

    4 days ago

    Sydney, New South Wales, Australia Lundbeck Full time $120,000 - $180,000 per year

    Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory submissions, maintaining licences and liaising with...

  • Manager, Regulatory Affairs

    2 weeks ago

    Sydney, Australia NSW Government -icare Full time

    **Open to all icare offices** - **Can work in Parramatta, Sydney-CBD, Newcastle, Gosford or Wollongong**: - **12-month maternity leave role, supporting Regulatory Affairs engagement**: - **Hybrid/flexible working model, positive work culture & competitive salary** ***About the Role** 12-month maternity leave cover opportunity available to support the...

  • Regulatory Affairs Specialist, JAPAC

    2 weeks ago

    Sydney, New South Wales, Australia Masimo Full time $90,000 - $120,000 per year

    Job DescriptionKey ResponsibilitiesPrepare, submit, and manage regulatory filings for product registrations, renewals, and variations across JAPAC markets.Monitor and interpret regional regulatory requirements to ensure ongoing product compliance and timely updates.Collaborate with cross-functional teams (R&D, Quality, Marketing, and Commercial) to support...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Sydney, New South Wales, Australia Medtronic Full time $80,000 - $120,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic...

  • Head of Regulatory Affairs

    6 days ago

    Sydney, Australia iCare External Full time

    **Sydney CBD** - Key leadership role in icare’s Stakeholder Relations and Policy Team - Lead icare’s highly visible Regulatory Affairs team to build and maintain a high performing regulatory affairs function - Build and execute icare’s Regulatory Affairs strategy and provide expert advice on regulatory matters to icare’s Group Executive Team across...