Senior Regulatory Affairs - Medical Devices
Are you an experienced Reg Affairs professional in the medical device space? Looking for a flexible working arrangement?
Summary about this job
Pharmaceuticals & Medical Devices
Company: Pharmaceutical & Medical Professionals, an HPG Business
Location: Sydney
Work type: Contract/Temp
Salary: $90,000 - $100,000 FTE + Flex Working Arrangement
Phone: +61-8-9400-8645
Fax: +61-3-2602-8891
E-mail: n\a
Site: n\a
Detail information about job Senior Regulatory Affairs - Medical Devices. Terms and conditions vacancy
About the company
A global leader who specialize in medical innovation and are passionate about patient outcomes. They partner with clinicians to develop innovative technologies with a focus on heart valves and critical care technologies.
About the opportunity
This global medical device company requires an experienced Regulatory Affairs professional to join the team. Your role will support the current Regulatory Manager with all pre- and post-market regulatory activities. This is a 12 month contract initially with a view to becoming permanent. We will review candidates looking for full-time and part-time for this position.
Duties
- Provide assistance across all regulatory functions where required
- Ensure regulatory compliance by updating company procedures and guidelines
- Maintain regulatory databases and monthly reports
- Liaise with global regulatory teams and cross functional teams
- Prepare, review and submit product registrations and variations
- Maintain medical device entries on ARTG and NZ WAND
Skills and Experience
- Ideally 4+ years in Regulatory Affairs within Australia
- Strong knowledge of medical device registration process.
- Experience liaising directly with the TGA and/or Medsafe
- Experience reviewing policies and procedures to improve processes
- Strong team player with excellent communication skills
- Effective time management and the ability to work autonomously
Culture
Passionate about patients, employees and career development
Benefits
- You will work closely with experienced regulatory professionals to gain valuable knowledge working with a range of medical device products
- Flexible working arrangement for part-time option
How to Apply
Click apply or contact Joanna Murphy, Recruitment Consultant on 02 8877 8718 for a confidential discussion.
About us
Pharmaceutical & Medical Professionals, a Healthcare Professionals Group business. Recruiting all positions, at all levels, into biotechnology, medical devices, pharmaceutical and scientific companies. For more pharmaceutical or medical related job opportunities visit www.pmpconnect.com. For other healthcare related job opportunities visit www.hpgconnect.com
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