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Regulatory Affairs Co-ordinator

Employer
mexec
Location
Port Melbourne, Australia
Salary
Competitive
Start date
18 Jun 2024
Closing date
18 Jul 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

  • Medical Devices
  • Full-Time
  • ANZ
The Client
Our client has built a highly successful product distribution network within ANZ and represents many leading international brands and manufacturers in the home healthcare device industry including several household names.

The Opportunity
Our client is seeking a new part-time Regulatory Affairs Co- ordinator to join their team. Your key remit will be to maintain full regulatory compliance for all our client’s products, working closely with expert consultants in the field. The duties performed within this position will include:
  • Developing and maintaining a regulatory affairs checklist and dossier for each product, including periodic auditing.
  • Liaising with Regulatory Bodies if required, including TGA/Medsafe, ACCC/NZCC, AICIS/EPA NZ, ACMA/MBIE NZERAC/EESS and others.
  • Compiling of documentation for ARTG/WAND entries/variations/restricted representations etc. for submission.
  • Arranging testing for products to ensure meet applicable standards as required.
  • Liaising with NPD team and manufacturers directly to ensure regulatory compliance with all new products as part of the development stage, including proofing instruction manuals, packaging, rating labels etc. and advising of updates / re-work that is required.
  • Keeping up to date with new, updated and emerging regulations and ensuring JAD product compliance.
  • Ensuring all rework procedures are kept up to date (both internal and external) and notifying relevant internal parties for any in-house rework requirements.
  • Providing advice regarding regulatory advertising guidelines for all JAD products across both digital and print marketing. E.g. proofing release sheets, catalogues, POS, social media, websites, eDMs, blog articles etc.
  • Ensuring compliance with Unique Device Identifier (UDI) requirements and updating the Australian UDI Database (AusUDID).
The Ideal Candidate
  • A team player with a willingness to learn and grow within the role and work closely with external consultants.
  • Experience with regulatory frameworks and processes pertaining to the sales and distribution of Class I and II medical devices within ANZ. Experience with home healthcare devices (non-medical) is also ideal.
  • Strong organisational and problem-solving skills, attention to detail, team player and a keen interest in learning more about regulatory affairs.
The Application
To learn more about this exciting opportunity, please email any questions you may have to careers@mexec.com or call 1300 063 932 to arrange a confidential discussion with Mark Thomas or Shayalini Wignarajah. To apply, visit our website at www.mexec.com and click Apply Now to submit a copy of your current CV and cover letter.

mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.

We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.

Company

Find out more about working for our company

mexec-career-hub-button

Brief Company Description; 

mexec is an Executive Search Recruitment firm that also provides support to individuals seeking to transition to a new role. 

We specialise in the science, health and innovation sectors. 

mexec are experienced in resourcing staff for companies including executive search and selection services to build your leadership team. 

We offer comprehensive services for individuals including our mexec jobstrategyTM program, résumé writing, LinkedIn profile updates and interview coaching. 

mexec works at all levels from graduate to CEO and board.

 

hub-icon-mexecPlease visit our Careers Hub on https://www.pharmiweb.jobs/minisites/mexec-agency-careers-hub/

 

 

 

Company info
Website
Mini-site
mexec
Telephone
1300 0 63932
Location
16 Harold Street
Blackburn
VIC
3130
AU

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