Posted: 15 May 2025
The Company
Our client is a medical device company dedicated to developing cutting-edge products from their clinically supported technology platform. By increasing patient adherence to prescribed medications, they hope to reduce hospitalisations and improve the health outcomes of patients with asthma and chronic obstructive pulmonary disease.
The Opportunity
Leading a team of three specialists in quality and regulatory affairs, you will work cross-functionally to oversee all aspects of quality and regulatory compliance across the business. In doing so, you will help to develop, refine, and improve the systems and processes required to successfully deliver innovative new products to global markets:
- Develop and implement comprehensive quality and regulatory strategies to support product development and commercialisation activities.
- Work closely with R&D, manufacturing, clinical, and marketing teams to refine and improve organisational approaches to maintaining quality standards and regulatory compliance.
- Oversee the development, implementation, and maintenance of robust Quality Management Systems (QMS) in compliance with ISO 13485 and other relevant standards.
- Identify potential quality and regulatory risks and develop mitigation strategies to ensure smooth product development and market entry.
- Provide regulatory guidance and support throughout the product development lifecycle, from concept to commercialisation.
- Prepare and submit regulatory filings, applications, and manage interactions with regulatory authorities.
- Lead training programs to ensure that all employees are knowledgeable about quality and regulatory requirements and best practices.
The Requirements
- Minimum of 8-10 years of experience in quality and regulatory affairs within the medical device industry
- Extensive knowledge of global regulatory requirements, including those of the TGA, FDA, EU MDR, and other international regulations relevant to the business and its operations.
- Proven experience in developing and maintaining Quality Management Systems (QMS) in compliance with ISO 13485 and a good understanding of IEC standards including IEC 60601-1, 60601-1-2, and 62304.
- Excellent written and verbal communication skills, with a strong desire to work cross-functionally with other teams within the business and communicate information regarding quality and regulatory requirements.
The Offer
The successful candidate will join a team who are excited about their products and the potential they have to positively impact patient’s lives. Please email any questions you may have to careers@mexec.com or call 1300 063 932 to arrange a time for a confidential discussion with Mark Thomas or Marilyn Jones.
To apply, please visit www.mexec.com and click Apply Now to submit your current CV and cover letter.
