Senior Regulatory Affairs Specialist

15 hours 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 value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

The Senior Regulatory Affairs Specialist (RAS) - INTERNATIONAL will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within Asia Pacific markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).

Responsibilities may include the following and other duties may be assigned:

 

  • Partner with local country RA affiliates to help planning, developing, and executing global regulatory activities necessary to obtain and maintain regulatory approvals in APAC region.

  • Interact with local RA team within APAC region and provide support needed.

  • Support and strengthen communication process between international RA and operating unit RA team.

  • Supports local RA team to prepare local submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.

  • Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.

  • Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.

  • Assist in keeping company informed of regulatory requirements in APAC region.

  • Supports product demand planning and release activities.

  • ·Follow all assigned standard operating procedures and company policies to ensure compliance.

  • Supports all post markets regulatory requirements and audit requests.

  • Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region.

  • Other duties as assigned or required.

 

Required Knowledge and Experience:

  • Bachelor's degree required with a minimum of 3-5  years of medical device regulatory affairs experience.

  • Medical Device regulatory submission/approval experience.

  • Knowledge of Asia Pacific regulations/requirements (eg TGA, PMDN, MFDS, ).

  • Strong Interpersonal and analytical skills.

  • Strong communication and technical writing skills.

  • Attention to detail.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About Medtronic

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 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here  
 

  • Senior Specialist Regulatory Affairs – Incubation

    2 weeks ago

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

    Job SummaryThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory...

  • NSW | Senior Regulatory Affairs Specialist | Medical Devices

    16 hours ago

    Sydney, New South Wales, Australia Heng & Hurst Full time $120,000 - $180,000 per year

    We're proud to partner with a global medical technology company on an ambitious journey to become one of the world's leading device manufacturers. Their diverse product portfolio features trusted, high-quality brands that are well-established in hospitals and healthcare settings. Headquartered in Sydney and backed by a strong international network, the...

  • Regulatory Affairs Assistant

    2 weeks ago

    Sydney, New South Wales, Australia W Cosmetics Full time $104,000 - $130,878 per year

    W Cosmetics – Regulatory Affairs AssistantWelcome to W Cosmetics, your gateway to a world of beauty Our mission is to offer beauty seekers of all ages, genders, and backgrounds a one-stop-shop experience in our Beauty Wonderland. We pride ourselves on curating a diverse range of the most unique and sought-after products from the global beauty industry,...

  • Regulatory Affairs Manager

    17 hours 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...

  • Regulatory Affairs Specialist, JAPAC

    1 week 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...

  • Public Affairs Manager

    2 weeks ago

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

    Join VELUX Australia as our Regulatory and Public Affairs Manager, a pivotal role in advocating for healthier buildings with more natural light and fresh air indoors.You will ensure regulatory frameworks support the integration of VELUX products into modern construction and renovation projects, collaborating with policymakers, industry organizations, and...

  • Regulatory Affairs Manager

    1 week ago

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

    About us…Since 1992, Device Technologies has been dedicated to improving patients' lives through leading edge technology and services,supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world.Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support...

  • Regulatory Relations Senior Specialist

    6 days ago

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

    Why join us?We're committed to building a stronger, more client-focused organisation. As we navigate a dynamic regulatory landscape, this role offers the opportunity to make a meaningful impact to our clients and stakeholders, by strengthening how we manage incidents. You'll work alongside senior leaders and stakeholders, help shape frameworks and develop...

  • Regulatory Associate

    1 week ago

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

    About DBG Health & VidaCorp:DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the wellbeing of all people. DBG Health's consumer division, VidaCorp, builds brands in health,...

  • Director - Regulatory Advisory

    4 days ago

    Sydney, New South Wales, Australia Aon Corporation Full time $120,000 - $200,000 per year

    Lead with impact – Build Aon Australia regulatory strategy and engage directly with senior team members and regulators.Purposeful culture – Work in a team that values ethics, appreciation, collaboration and don't settle for good enough – they ask what better looks like.Influence – Become a trusted adviser for senior collaborators and influence...