Regulatory Affairs Associate

vor 2 Monaten

Sydney, Österreich Stryker Vollzeit

This is a Regulatory Affairs Associate role with one of the leading companies in AU right now 🔥 -- Stryker -- with an amazing team. They are continuing to grow rapidly. This is the chance to join right as the 🚀 takes off.

More About the Role at Stryker 🧐🧐

**Job description** If you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you. We are looking for a **Senior Regulatory Affairs Associate** to join the high performing regulatory team. The successful candidate will bring experience to compliment the existing RA team of four. We are looking for someone who has at least 5 years' experience within Regulatory Affairs. The ideal candidate will come with experience of Class III and TGA conformity assessment applications. This role will suit an individual who is currently operating at Senior level or is ready to step up from Associate into Senior level. Whilst experience is key, the successful candidate will be a true team player, a hard-worker, enthusiastic and collaborative. **Responsibilities** - Prepare and submit device registration applications including complex submissions such as Class III and/or TGA Conformity Assessment applications. - Review and determine the impact of change notifications for existing devices, including management of registration updates and stakeholder communication. - Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions. - Work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe and Corporate requirements. - Operate with a significant degree of efficiency and independence. - Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements. - Maintain corporate compliance by supplying information as required by the Therapeutic Goods Administration (TGA) and Medsafe. - Develop new regulatory processes and continuous process improvements. - Develop and maintain strong relationships with MedTech Industry and the TGA to leverage advocacy opportunities including health policy in line with the business strategy - RA Assistant/Associate level mentorship **Skills & Requirements:** - Minimum 5 years’ experience in a similar Regulatory Affairs role. - Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related). - High attention to detail and deadline oriented - Self-driven, strategic thinker with the ability to thrive in a fast-paced and high growth company - Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing. - Strong knowledge of the Medical Device regulations in Australia and New Zealand. International regulatory knowledge desirable e.g. FDA and EU MDR - Strong negotiation and communication skills to effectively build relationships with key stakeholders, industry bodies and regulatory authorities. **Culture and Benefits:** At Stryker, you can expect an attractive package including a broad range of discounts and benefits from a range of partners This is a genuine opportunity for an ambitious and customer focused individual to progress and grow your career with a leading global medical device company that offers countless development opportunities. Some of our benefits include: - Multiple financial benefits including health care, financial wellbeing, insurance benefits.  - Paid Parental leave schemes - Volunteer Days - Being part of one of the world’s largest and most recognizable brands. - Excellent team culture – we have fun whilst we work - A Leader who will support & guide you throughout your career - Access to our career and self-development program from day one - Work with likeminded individuals who are driven by exceeding targets and improving patient outcomes

🚨🚨 If you don’t think you're a perfect fit, you should still sign up to Hatch and create a profile, we'll match you to other roles that suit your profile.

Hatch exists to level the playing field for people as they discover a career that’s right for them. We model this in our hiring process for our partners like Stryker.

✅ Applying here is the first step in the hiring process for this role at Stryker.

We do not discriminate on the basis of gender identity, sexual orientation, cultural identity, disability, age, or any other non-merit factors. To put it simply, Hatch is for everyone.

  • Senior Regulatory Affairs Associate

    vor 2 Wochen

    Sydney, Österreich Novo Nordisk Vollzeit

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the department You will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    vor 4 Wochen

    Sydney, Österreich Novo Nordisk Vollzeit

    Are you passionate about regulatory affairs?Do you want to play a key role in ensuring the availability of life-changing medicines?If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.Read more and apply today for a life-changing career! About the department You will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Are you passionate about regulatory affairs?Do you want to play a key role in ensuring the availability of life-changing medicines?If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.Read more and apply today for a life-changing career! About the departmentYou will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Stryker Vollzeit

    Work Flexibility: HybridIf you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you.We are looking for a Senior Regulatory Affairs Associate to join the high performing regulatory team.The successful candidate will bring experience to complement the existing RA team of four.We are looking for someone who has at least...

  • Senior Regulatory Affairs Associate

    Vor 5 Tagen

    Sydney, Österreich Astrazeneca Vollzeit

    ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.Our leadership style is progressive, committed to collective success, fostering high performance and strong team connections,...

  • Senior Regulatory Affairs Associate

    Vor 5 Tagen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.Our leadership style is progressive, committed to collective success, fostering high performance and strong team connections,...

  • Regulatory Affairs Associate

    Vor 3 Tagen

    Sydney, Österreich I-Pharm Consulting Vollzeit

    Regulatory Affairs Associate - 1 year FTCJoin a leading global healthcare company as a Regulatory Affairs Associate (1 year FTC). In this role you will assist the Regulatory Affairs team with the review of all existing Medical Device registrations and new product registrations for Australia and New Zealand.The role will include evaluation, submission,...

  • Regulatory Affairs Associate

    Vor 2 Tagen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Regulatory Affairs Associate - 1 year FTC Join a leading global healthcare company as a Regulatory Affairs Associate (1 year FTC).In this role you will assist the Regulatory Affairs team with the review of all existing Medical Device registrations and new product registrations for Australia and New Zealand.The role will include evaluation, submission,...

  • Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Dbg Health Vollzeit

    Great opportunity to get your foot in the door with a market leading pharmaceutical company.11th October, 2024DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the well-being of...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Great opportunity to get your foot in the door with a market leading pharmaceutical company.11th October, 2024 DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the well-being of...

  • Associate Director, Regulatory Affairs

    vor 3 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity.Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...

  • Associate Director, Regulatory Affairs

    vor 4 Wochen

    Sydney, Österreich Pharmalex Gmbh Vollzeit

    We are growing, grow with us! Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective...

  • Associate Director, Regulatory Affairs

    vor 3 Wochen

    Sydney, Österreich Pharmalex Gmbh Vollzeit

    We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Sydney, Österreich Advanced Accelerator Applications (Italy) - S... Vollzeit

    Internal Role Title: Regulatory Affairs ManagerLocation: Sydney, Australia #LI-HybridAbout the Role:As Regulatory Affairs Manager you will manage, plan and coordinate submissions to health authorities in Australia and New Zealand.Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensure compliance...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Internal Role Title: Regulatory Affairs Manager Location: Sydney, Australia #LI-Hybrid About the Role: As Regulatory Affairs Manager you will manage, plan and coordinate submissions to health authorities in Australia and New Zealand.Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensure...

  • Regulatory Affairs Associate

    vor 4 Wochen

    Sydney, Österreich Dbg Health Vollzeit

    This is an excellent opportunity to be part of a forward-thinking pharmaceutical company that values your expertise and insights.04th September, 2024 About DBG Health & VidaCorp: DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.With a team of over 1,000 dedicated professionals, we are committed to delivering...

  • Senior Regulatory Affairs Associate

    vor 4 Wochen

    Sydney, Österreich Dbg Health Vollzeit

    This is an excellent opportunity to be part of a forward-thinking pharmaceutical company that values your expertise & insights.02nd October, 2024About DBG Health & VidaCorp:DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.With a team of over 1,000 dedicated professionals, we are committed to delivering...

  • Regulatory Affairs Coordinator

    vor 3 Wochen

    Sydney, Österreich Resmed Inc Vollzeit

    Regulatory Affairs CoordinatorApply locations Sydney, NSW, AustraliaTime Type: Full timePosted on: Posted YesterdayJob Requisition ID: JR_035534The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...

  • Senior Manager, Regulatory Affairs

    vor 4 Wochen

    Sydney, Österreich Pharmalex Gmbh Vollzeit

    We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity.Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the marketdevelopment and any action of...

  • Senior Manager, Regulatory Affairs

    vor 2 Wochen

    Sydney, Österreich Pharmalex Gmbh Vollzeit

    We are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...