Buscojobs | Senior Manager

vor 7 Stunden

Central Coast, Österreich Tideri Jobbörse Vollzeit

Permanent full-time position to drive quality initiative across a global business
Enjoy excellent work-from-home flexibility
Are you an experienced Quality and Regulatory professional ready to take on a transformative leadership role?
Our client, an ASX listed medical device company, is seeking a Senior Manager – Global Regulatory Affairs & Quality Assurance to lead their global operations through an exciting growth phase.

This is an outstanding opportunity to join a company at a critical juncture, as they transition to a world-class medical device organisation.
With innovative projects in the pipeline and a focus on operational excellence, this role offers the chance to make a significant impact on a global scale.

Reporting to the Global Director of Quality Assurance and Regulatory Affairs, you will play a pivotal role in driving the quality assurance activities of their overseas manufacturing site.
Your key responsibilities will include but will not be limited to:
Being a Change Maker: Driving cultural and operational transformation, embedding quality into the core of all processes and fostering a proactive, collaborative approach across departments.
Driving Global Compliance: Overseeing regulatory and quality functions, ensuring alignment with ISO 13485, GMP, TGA, FDA, CE, and other global standards.
Elevating Manufacturing Operations: Providing regulatory guidance and quality oversight for the overseas manufacturing facility, supporting audits, resolving quality issues, and mentoring the on-site team.
Leading Strategic Initiatives: Supporting the global transition to an electronic QMS.
Collaborating with internal stakeholders: Working with R&D, Sales, Marketing, and Supply Chain teams to align quality initiatives with business objectives.
Providing hands-on coaching: Mentoring junior team members, building their expertise and confidence.
In order to be considered for this role, you will have the following qualifications and skills:
A Degree in Life Sciences A minimum of 8 years of quality assurance and/or regulatory affairs experience in the medical device industry.
Previous quality experience within a manufacturing environment.
The ability to influence stakeholders, build cross-functional collaboration, and drive accountability.
A proactive, hands-on approach, thriving in dynamic, fast-paced environments.
Previous line management experience.
Previous experience working with Asian countries will be valued.
If you are an ambitious, hands-on and solutions-focused professional, I would love to hear from you
For a confidential conversation about this role, please call Grace Bitodi on 029431 2540.

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