Regulatory Affairs Strategist

1 day ago

Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Strategist to join our high-performing regulatory team at Stryker Australia Pty Ltd.

Job Description

This senior role will focus on preparing and submitting device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications. You will work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe, and Corporate requirements.

The successful candidate will have experience in regulatory affairs, particularly in Class III and TGA conformity assessment applications, and be able to operate with a significant degree of efficiency and independence.

Key Responsibilities:
  • Prepare and submit device registration applications, including Class III and/or TGA Conformity Assessment applications.
  • Review and determine the impact of change notifications for existing devices.
  • Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions.
  • Work closely with key stakeholders to process regulatory actions.
  • Maintain corporate compliance by supplying information as required by the Therapeutic Goods Administration (TGA) and Medsafe.
Requirements:
  • Minimum 5 years' experience in a similar Regulatory Affairs role.
  • Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related).
  • Strong knowledge of Medical Device regulations in Australia and New Zealand.
  • Excellent communication and negotiation skills.
About Our Company

Stryker is a leading global medical device company that offers countless development opportunities. As a member of our team, you can expect an attractive package including a broad range of discounts and benefits from a range of partners.

We offer multiple financial benefits, paid parental leave schemes, volunteer days, and access to our career and self-development program from day one.

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