Apac Regulatory Affairs Manager

7 days ago

Sydney, New South Wales, 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.

  • Manager, Regulatory Affairs, Apac

    1 week ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Job title Manager, Regulatory Affairs, APAC Function Regulatory Affairs Group Sub function Regulatory Affairs Category Manager, Regulatory Affairs (P7) Location Singapore / Mongkok / North Ryde / Petaling Jaya / Seoul / Taipei City / Singapore / Hong Kong / Australia / Malaysia / Korea, Republic of / Taiwan Date posted Sep 02 2025 Requisition number R-030104...

  • Manager, Regulatory Affairs, APAC

    1 week ago

    Sydney, New South Wales, Australia Johnson & Johnson Innovative Medicine Full time

    OverviewJohnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate...

  • Manager, Regulatory Affairs, APAC

    1 week ago

    Sydney, New South Wales, Australia Johnson & Johnson Innovative Medicine Full time

    OverviewJohnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate...

  • Regulatory Affairs Manager

    1 week ago

    Sydney, New South Wales, 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 and...

  • Regulatory Affairs Specialist

    6 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Job SummaryClinical professionals looking to develop their expertise in regulatory affairs will find this role a stimulating challenge. We seek a detail-oriented and highly motivated Regulatory Affairs Specialist to support our team.Key Responsibilities:Support the preparation and submission of regulatory documents.Maintain accurate records and provide...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $120,000

    Regulatory AssociateThe ideal candidate will be responsible for supporting regulatory activities across a global portfolio, ensuring products meet the highest standards of compliance and regulation.This role requires a detail-oriented and motivated individual with a strong background in regulatory affairs or a related field within the pharmaceutical or...

  • Regulatory Affairs Lead

    2 weeks ago

    Sydney, New South Wales, Australia i-Pharm Consulting Australia Pty Ltd Full time $90,000 - $120,000 per year

    Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company?This is a fantastic opportunity to join a well-established business recognised for its strong culture and high-quality products used in healthcare settings worldwide.In this role, you'll take the lead on regulatory activities...

  • Regulatory Affairs Expert

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000

    About This RoleWe are seeking a highly skilled Regulatory Specialist to join our team. In this role, you will be responsible for driving Kuiper's compliance strategy and performing advocacy consistent with our policy priorities.The successful candidate will have experience in regulatory advocacy, supporting complex compliance requirements, and working...

  • Apac Regulatory Strategy Professional

    5 days ago

    Sydney, New South Wales, Australia Bebeeregulatory Full time

    Job Title: Regulatory Affairs ManagerThe successful candidate will lead the development and implementation of regulatory strategies for assigned products in the APAC region. The role requires collaboration with cross-functional teams, local operating companies, and health authorities to ensure compliance with regional regulatory requirements.Key...

  • Business Process Manager- Regulatory Affairs

    1 week ago

    Sydney, New South Wales, Australia Resmed Full time

    We are looking for a **Business Process Manager - Regulatory Affairs**to lead a dedicated team focused on optimizing regulatory workflows and ensuring global compliance across our operations. This is a critical leadership role where you'll work cross-functionally to drive business efficiency, support transformation, and elevate the performance of the...