Regulatory Affairs Specialist - Australia
Corin, Australia
Job Description
About the job
Corin Australia is looking for an experienced and motivated Regulatory Affairs Specialist to join the Optimized Ortho (Technology) division of our growing team. This is a full-time, ongoing position and will be based out of our Sydney office located in Pymble, close to public transport. At Corin we recognize that we are living and working in a constantly changing, fast-paced world and we are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. This includes options to flexibly shift your work times and work from home.
We are a small, but rapidly growing company, so we are looking for individuals who want to grow, develop, learn and contribute to our team. You will pride yourself on your ability to work collaboratively and independently in a cross-functional team environment. A positive attitude to change and a passion for improving patient lives is essential.
What you will be doing:
- Managing various tasks for Corin’s portfolio of metal and plastic products as well as our technology offerings
- Preparing and maintaining technical files and design dossiers
- Compiling, reviewing and submitting regulatory submissions to various global notified bodies including but not limited to the TGA and the FDA
- Participating in cross-functional projects to provide regulatory strategy and oversight for implantable device and technology development projects locally and globally
- Driving improvement projects across the Regulatory function
- Reviewing protocols amp; reports and other documentation used to support medical device files
- Remaining up to date with changes within the industry and regulatory environments and performing subsequent gap analyses to understand the effect of changes
- Providing mentorship and knowledge sharing within the regulatory team
- Supporting internal/external audits as required
Requirements
On your first day, we'll expect you to have:
- 2+ years prior experience in a regulatory role within the medical device industry
- A tertiary qualification in Biomedical Engineering or Lifesciences
- Proficiency with technical communication and related software
- Experience operating in an 21 CFR.820, ISO 13485 or ISO 9001 QMS
- Proficient knowledge of Therapeutic Goods (Medical Devices) Regulations 2002
- Proficient knowledge of EC Directive 93/42/EEC and EU MDR 2017/745
- Proficient knowledge of FDA 21 CFR Part 803 and 21 CFR part 820
- Excellent written and oral communication skills
- Prior medical device experience or experience working within a regulated environment (bonus points for exposure to 62304 or 13485)
Benefits
More About Our Benefits
In return we will offer you a competitive remuneration and benefits package, opportunities for growth and development, within a dynamic and supportive team environment. At Corin we believe that to be successful at work, you need to enjoy what you do. You have to be rewarded for your efforts and motivated to keep going even when the pressure's on. We will help you to play to your strengths and develop and build a career you can be proud of.
More About Corin
As a leader in orthopaedic innovation, Corin has pioneered several landmark orthopaedic developments since its foundation in 1985. We are very proud that we have been able to improve the quality of life of thousands of patients around the world through these ground breaking products, and believe this heritage distinguishes Corin within the global orthopaedic market. Our technologies enable surgeons to perform patient-specific procedures and gain a unique level of insight and understanding allowing them to easily monitor progress and achieve the most positive results. Improving patient satisfaction is at the centre of everything we do by delivering personalised technologies that optimise our clinically proven joint replacements.
How to Apply
If you are looking for a rewarding and exciting opportunity to be part of a talented global team that positively impact lives, then please email your CV and covering letter to Jessica Hancox (Human Resources) at .
We will be looking to fill this position as soon as possible, please note that only shortlisted candidates will be contacted.
NO AGENCIES PLEASE