Quality Assurance & Regulatory Affairs Director

At Genea Biomedx we innovate fertility technologies to streamline lab workflow and transform fertility treatments. Our goal is to leverage our extensive expertise to deliver precise, accessible technology that significantly improves both performance and patient results.

Genea Biomedx is designing and manufacturing medical devices and technology that aims to simplify, standardize and automate fertility treatment. We offer potential employees the chance to join our team creating cutting-edge medical devices for the IVF industry.

Job Description

We are currently seeking an accomplished Quality Assurance (QA) and Regulatory Affairs (RA) leader with significant experience in medical devices, including senior management roles, to lead the QA and RA function at Genea Biomedx.

Reporting to the COO, the QA/RA Director will be the appointed management representative for the quality management system. The preferred candidate will bring deep expertise in EN ISO 13485 and ISO 14971, and a track record of building global regulatory strategies, obtaining and maintaining certifications, and leading Notified Body, Competent Authority and FDA audits.

This is an opportunity to shape the quality and regulatory direction of a fast-growing, innovative medical device business.

Responsibilities

- Acting as the appointed management representative and maintaining the quality management system in line with EN ISO 13485 and applicable regulatory requirements.
- Developing QA and RA processes, and ensuring departmental compliance with operating procedures, protocols, and policies.
- Overseeing the investigation and execution of CAPAs, change control, change requests and associated quality tools.
- Driving vendor quality performance.
- Ensuring Genea Biomedx is prepared for internal and external audits and approval programs.
- Partnering with internal manufacturing teams to manage, monitor and continuously improve product quality outcomes,



including supporting QA and QC process implementation and validation.
- Developing and defining test methods, and identifying, planning, and implementing product and production improvement initiatives.
- Providing QA sign-off for release of product to market and overseeing batch record maintenance and storage.
- Analysing and trending environmental and product monitoring data.
- Building global regulatory strategies and overseeing their implementation.
- Providing current regulatory information and developing and maintaining relationships with regulatory authorities, external suppliers, and key industry contacts.
- Preparing and submitting regulatory submissions and responses to queries from regulatory authorities.
- Providing regulatory advice to all departments, and preparing and reviewing regulatory documents, including feedback on regulatory-related customer documentation.
- Mentoring and training key personnel and building site-wide working knowledge of key regulatory requirements.

About the Position

We are seeking a strategic, hands-on quality and regulatory leader to head the Genea Biomedx QA/RA function who:

- Leads with initiative, sound judgement, and attention to detail.
- Manages time effectively and prioritises competing demands.
- Works effectively in charge of their own area of responsibility and as part of a team.
- Is comfortable operating at both a strategic and hands-on level, assisting in execution where required.
- Excels at communicating complex quality and regulatory information clearly and concisely, both verbally and in writing.
- Can effectively liaise with counterparts in other countries,



especially China.

Qualifications

To be successful in this role you will be a senior quality and regulatory skilled with demonstrated experience in QA and RA for medical devices with senior leadership exposure. You will have first-hand experience across the development, manufacture, marketing, and support of medical devices, both as a medical device manufacturer and as a regulatory professional.

Qualifications & Attributes

- Tertiary qualification in science, engineering, medicine, or a related discipline
- Demonstrated experience in quality assurance and regulatory affairs, including senior management roles.
- Proven experience creating, implementing, and auditing (internal and external) quality management systems based on EN ISO 13485 and medical device regulatory requirements.
- Expertise in obtaining and maintaining regulatory certifications.
- Experience leading Notified Body, Competent Authority and FDA assessments and audits.
- Working knowledge of ISO 14971, with the ability to execute and lead risk assessments.
- Knowledge of medical device regulatory requirements for demonstrating safety and performance, including V&V; activities and clinical evaluations.
- Excellent written and oral communication skills.
- Effective time management and prioritisation skills.

Additional Information

Working for Genea Biomedx

Our staff enjoy working at Genea Biomedx for several key reasons; flexibility, development opportunities, and fulfilment of working somewhere that truly makes a difference to people’s lives.

What’s in it for you?

- Genuine opportunities for career growth and professional development
- Project and spot bonus schemes
- Active social club.
- We are a certified family-friendly workplace.

If you’re ready to lead quality and regulatory affairs at a business that’s transforming fertility treatment worldwide, we’d love to hear from you.

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📌 Quality Assurance & Regulatory Affairs Director (Sydney)
🏢 Genea Biomedx Pty
📍 Sydney