Senior Regulatory Specialist

Vacancy number • PUB407451

Senior Regulatory Specialist

  • Melbourne
  • Closes May 27
  • 37.5 hours
  • Professional Bachelor

Start applying immediately

About this job

  • Market: Life Sciences & Health Care
  • Industry: Medical devices
  • Area of expertise: Regulatory
  • Location: Melbourne

What is required?

  • Hours per week: 37.5
  • Education level: Professional Bachelor
  • Closing date: Monday, May 27, 2024

Introduction

Brunel is currently partnered with a world-leading, ASX-listed biosensors company that is a major supplier to several different industries. They are searching for a Senior Regulatory Affairs Specialist for their office in the heart of Melbourne, with expertise in developing and implementing a clear global regulatory strategy.

About this role

  • Lead regulatory approval projects for medical products in key markets like EU and US
  • Manage clinical and vigilance aspects of new and existing products
  • Prepare and maintain medical device files for submission to global regulatory authorities
  • Maintain regulatory license databases and systems
  • Communicate with regulatory agencies and conformity assessment bodies
  • Provide regulatory support to ongoing projects as needed
  • Assist in coordinating post-market surveillance activities with FDA, TGA & EU IVDR requirements

What you need to bring:

  • BSc in a scientific field or related
  • Experience creating regulatory documentation for submissions
  • Strong experience with the following standards: ISO13485, ISO14971, 21 CFR 820
  • Ability to work flexibly across different timezones
  • Ability to work in a fast-paced environment and able to hit the ground running

Benefits:

  • Opportunity to work in a fast-paced environment
  • Great team culture
  • Competitive package (up to $130,000 dependent on experience)

Anything Else?

Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!

At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

Learn more about our global network of specialists!

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!

Start applying immediately

image Apply now Sending an application is quick and easy. Just make sure you have the required documents ready to go.

Any questions remaining?

Your consultant, Louise Cleland is happy to clarify anything about this vacancy. When reaching out, use this number: PUB407451

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