Regulatory Compliance Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time
Regulatory Affairs Lead Job Opportunity

We are seeking a highly skilled Regulatory Affairs Lead to oversee and drive key regulatory activities, ensuring compliance with relevant regulations and legislation.

  • Key Responsibilities:
    • Strategic regulatory guidance: provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
    • Risk management and compliance: identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;
    • Process improvement and implementation: Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
    • Stakeholder engagement and issue resolution: act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and
    • Leadership and team development: Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team
Requirements:
  • A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
  • Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related);
  • Strong communication, negotiation and influencing skills – the ability to quickly build meaningful relationships with internal teams, external stakeholders and government departments; and
  • A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance and growth organisation;
  • 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
  • Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus (e.g. FDA and EU MDR); and
  • Experience with Prostheses List management;
Benefits:

As a Regulatory Affairs Lead, you will have the opportunity to work in a dynamic and growing organization, contributing to the development of innovative products and services that improve patient and healthcare outcomes.

Our organization offers a collaborative and supportive work environment, with opportunities for professional growth and development.

You will be part of a team that is passionate about making a difference in the lives of patients and healthcare professionals.

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