Regulatory Affairs Manager

1 week ago

Sydney, Australia KE Select Full time

Part of the Leadership Team at DiaSorin
- Excellent opportunity to take the next step in your career
- Stand alone role looking after ANZ with some APAC responsibilities

**About The Company**
KE Select have partnered exclusively with DiaSorin to uncover their next Regulatory Affairs Manager for ANZ. DisSorin is the global leader in the Molecular Diagnostics and Immunodiagnostics market and for over 50 years they have been developing, manufacturing and marketing state-of-the-art solutions and specialty tests for laboratories all over the world.

**About the Role**
Due to the upcoming retirement of their current Regulatory Affairs Manager for ANZ, we are looking for the next superstar to take on this pivotal role in ANZ. This is a permanent full-time position that could be based from anywhere in Australia, with the requirement to travel as required to the head office in Sydney. We are looking for someone to start around the end of June with the added benefit of a handover period with the incumbent. This is a pivotal role in the organisation, predominantly stand alone, providing additional support to the APAC region.

Reporting to the Commercial Director, as the RA Manager, you will be responsible for maintaining and upholding the company’s regulatory profile with the TGA and other regulatory bodies. You will ensure that products comply with regulations and laws governing their importation, sale and distribution. In addition, you will help develop, drive and monitor the company regulatory plans and procedures, while also providing training and development to the team. Some of the responsibilities are as follows:

- Build relationships both internally and with the applicable regulatory authorities
- Prepare product registration submissions for new products and change notifications for existing products
- Execute the IVDR transition project
- Maintain up-to-date knowledge and information on the regulatory environment for medical devices in Australia and New Zealand
- Support and carry out Field Corrective Actions with Regulatory Authorities
- Be the key contact and bridge for the local organisation to the DiaSorin Group in Regulatory & Quality for market vigilance and regulatory compliance activities
- Assist with tenders and cross functional interactions with sales
- Other duties as required

**About You**
To be successful in this role you will have the following:

- Relevant Bachelor’s degree or higher
- Significant experience in the development and implementation of RA processes/management, preferably in IVD or medical devices
- Class IV registration experience would be highly regarded
- Experience in a similar role and looking for the next step up
- Familiar with relevant statutes and industry standards, such as ISO 13485, IVDD, GMP, FDA Quality and System Regulations, CFR
- Flexibility to travel both domestically and internationally, as required
- Excellent communication skills, both verbal and written, and ability to build relationships with key stakeholders
- Full working rights in Australia

KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Medical Device and Clinical space.

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