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Manager - Regulatory Affairs

Stryker

Job Description

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com


As Regulatory Manager you will be joining a highly sought-after team in the Stryker community. The Regulatory Manager overseas a high achieving and dynamic team within our Government and Regulatory Affairs division.

The main purpose of this Regulatory Manager is responsibility for ensuring compliance with all requirements of relevant regulations and legislation. The role provides management and oversight of regulatory activities ensuring that they are aligned with business outcomes. This is a people leader role, leading, managing and developing of RA Associates, Senior RA Associates, RA Assistants and Interns in the team.

Responsibilities:

  • Manage and support the Regulatory team to achieve product registration approvals/market access opportunities to allow business growth.
  • Drive business partnerships with various divisions in the business.
  • Organise and schedule regular touch points with stakeholders, to build network and relationships in order to escalate and leverage for support when needed.
  • Develop new regulatory processes and provide process improvement advice to improve RA compliance and efficiency, and concomitant business ramifications.
  • Provide strategic regulatory advice for smooth integration of business acquisitions.
  • Maintain strong relationships with the Therapeutic Goods Administration (TGA) and Medsafe, being a brand ambassador for Stryker.
  • Champion involvement with MTAA and represent Stryker at industry events.
  • Highly compliant focused with SSP compliance and ISO requirements.
  • Manage complex high-risk submissions for required products.

Skills & Requirements:

  • Experience in managing and leading people
  • Passionate about developing people
  • A minimum of 5+ years demonstrated success in Regulatory Affairs
  • Excellent negotiation and communication skills to effectively build relationships with key stakeholders and members of government departments.
  • Demonstrated leadership qualities.

Culture & Benefits

  • Join one of Australia’s (and the world’s) Best Places to Work since 2014!
  • Grow and develop your Supply Chain career with a company that prides ourselves on personal and professional development
  • Free on-site gym and parking!

To join us, click apply now!


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