Regulatory Compliance Manager for Medical Devices

2 weeks ago


Mascot, Australia Boston Scientific Full time

About Boston Scientific

Boston Scientific is a global leader in the medical device industry, committed to delivering innovative solutions that improve patient outcomes.

Job Overview

We are seeking an experienced Regulatory Compliance Manager to join our Australia and New Zealand (ANZ) Regulatory Affairs team. As a key member of our team, you will play a critical role in ensuring the timely preparation and submission of regulatory documents to the Therapeutic Goods Administration (TGA) and MedSafe, while maintaining compliance with ANZ regulations.

About the Role

The successful candidate will be responsible for developing and maintaining sound regulatory strategies for market entry in ANZ, including identifying potential issues early in the planning process. This will involve compiling, preparing, reviewing, and submitting regulatory dossiers to regulatory authorities, as well as managing changes to existing products to ensure continued compliance with regulations and supply continuity.

Key Responsibilities

  • Regulatory Knowledge and Application
    • Determine and maintain sound regulatory strategies for market entry in ANZ
    • Compile, prepare, review, and submit regulatory dossiers to regulatory authorities
    • Manage changes to existing products to ensure continued compliance to regulations and supply continuity
    • Maintain up-to-date knowledge of regulatory requirements and changes in ANZ
    • Liaise with regulatory authorities and negotiate submission details
    • Collaborate with cross-functional teams to support product commercialization in ANZ
  • Business Partnering
    • Represent Boston Scientific values and perform your role with integrity
    • Build relationships with corporate regulatory teams to get timely information required for ANZ submissions
    • Effectively partner with sales, marketing, operations, and other stakeholders to develop sound product and business strategies
  • Continuous Improvement
    • Liaise with multiple stakeholders across all levels of the organisation
    • Take part in continuous improvement projects

What We Offer

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, as well as a comprehensive benefits package. If you are a motivated and experienced regulatory professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

Requirements

To be successful in this role, you will need a minimum of 2 years of experience in regulatory affairs within the medical device industry. A Bachelor's degree in science, engineering, or a related field is desirable, as is experience with Australian Therapeutic Goods Administration (TGA) regulations. Familiarity with international regulations and requirements is ideal, and excellent written and verbal communication skills are essential.

How to Apply

If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application, including your resume and a cover letter outlining your experience and qualifications. We thank all applicants for their interest; however, only those selected for an interview will be contacted.



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