Regulatory Affairs Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $120,000
Job Description

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. In this role, you will be responsible for managing regulatory activities to ensure all RA documentation and approvals are current and up-to-date for all products supplied in Australia and New Zealand.

The successful candidate will have experience in working directly with regulatory agencies or similar demonstrated experience, and a strong understanding of Class III Medical Devices/Conformity Assessment Submissions with TGA.

Key responsibilities include:

  • Managing, coordinating and performing regulatory activities to ensure all RA documentation and approvals are current and up-to-date
  • Ensuring post-market surveillance and regulatory reporting obligations are met in a timely manner
  • Compiling and submitting registration dossiers for new products in Australia and NZ
Requirements

To be successful in this role, you will need to possess the following skills and qualifications:

  • Tertiary qualification in Pharmacy/Life Science or Chemistry/Engineering or similar field
  • Experience in working directly with regulatory agencies or similar demonstrated experience
  • Significant hands-on experience with Class III Medical Devices/Conformity Assessment Submissions with TGA desirable but not mandatory
  • Excellent communication and teamwork skills
What We Offer

We offer a dynamic and supportive work environment, with opportunities for professional growth and development.

In return for your hard work and dedication, we offer a competitive salary package and benefits, including a comprehensive training program and ongoing support for your career advancement.

About Us

As a leading innovator in musculoskeletal healthcare, we are committed to delivering high-quality products and services that meet the needs of patients and healthcare professionals worldwide.

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