Regulatory Affairs Specialist

11 hours ago

Sydney, New South Wales, Australia Hengandhurst Full time
Regulatory Affairs & Quality Assurance Manager

Are you a seasoned professional looking for a new challenge in the medical devices industry? We have an exciting opportunity for a Regulatory Affairs & Quality Assurance Manager to join our team at Hengandhurst.

About the Role

We are seeking a highly motivated and experienced individual to lead our regulatory affairs and quality assurance efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies, ensuring compliance with relevant standards and regulations, and managing our quality management system.

Key Responsibilities:

  • Develop and implement regulatory strategies for device approval and compliance
  • Prepare and submit regulatory applications and ensure timely compliance
  • Manage and update our quality management system to ensure ISO 9001 standards are met
  • Conduct audits and implement corrective actions as needed
  • Post-Market Surveillance: handle complaints, adverse events, and recalls, and implement corrective actions with cross-functional teams
  • Stay up-to-date on regulatory trends and communicate changes to the team
Requirements

To be considered for this role, you will have:

  • Bachelor's degree in a relevant scientific or engineering discipline; advanced degree is a plus
  • Multiple years of experience in regulatory affairs and quality management within the medical devices industry
  • Ability to work to deadlines and prioritize tasks with strong attention to detail and project management skills
  • Driven mindset, hands-on approach, and supportive personality
  • Excellent communication and interpersonal skills, with the ability to work collaboratively across departments
About Hengandhurst

Hengandhurst is a top-tier medical device distribution company with a wide, diversified, and exciting portfolio. We are a highly collaborative and warm team, with a diverse and growing portfolio across the ANZ market. We offer a great opportunity for a fast-growing long-term career and a chance to become part of a thriving, independent ANZ medical device company dedicated to expanding its portfolio and product offerings.

We are renowned for our robust culture, seasoned professionals, and top-tier products, and have achieved growth not only through business triumphs but also by strategically acquiring new products for distribution. We are committed to expanding our team and are seeking an ambitious and motivated Regulatory Affairs & Quality Assurance Manager to join us on this exciting journey.

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your CV in word format, and we will be in touch to discuss further.

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