Senior Regulatory Affairs Associate
Manage regulatory activities for a world leader in medical technology who demonstrate a strong culture and ethics
Summary about this job
Pharmaceuticals & Medical Devices
Company: Healthcare Professionals Group
Location: Sydney
Work type: Full Time
Salary: bonus
Phone: +61-3-5495-7175
Fax: +61-2-2925-4722
E-mail: n\a
Site: n\a
Detail information about job Senior Regulatory Affairs Associate. Terms and conditions vacancy
About the company
Our client, an Employer of Choice, are a leading medical device company renowned for customer solutions to recognise the ever-growing health requirements worldwide. Currently, they have an opportunity for a Senior Regulatory Affairs Associate to join their medical division to participate in the ownership of all regulatory activities across both the Australian and New Zealand markets.
This is an exciting time to join this organisation since they are currently restructuring due to expansion and acquisition of new product portfolios and therefore the successful candidate will be given the opportunity to make this role their own through adding value to the regulatory function
Duties
The main responsibilities of the role will include, but not be limited to:-
- Manage all regulatory activities ensuring compliance to regulations and maintenance of product registrations is adhered to according to TGA, AQIS and Medsafe guidelines
- Promotional material review
- Undertake project work and provide guidance to project teams from a regulatory requirements perspective
- Liaison with Regional and Global stakeholders
- Develop strong relationships with the TGA, Medsafe and other relevant regulatory entities and associations ensuring industry changes and product knowledge remains current and shared with the wider team
- Maintain the Quality Management System in line with the organisations requirements
Skills and Experience
- Scientific, Engineering, Medicines or Pharmacy Degree
- Minimum 2 years’ relevant experience
- Strong knowledge of regulatory requirements for medical devices and IVDs in Australia and New Zealand
- Strong interactions and relationships with TGA and other relevant industry bodies
- Proactive and confident with strong business acumen and the ability to prioritise
- Excellent written communications
- Attention to detail
Culture
As an Employer of Choice this organisation has strong core values which have cemented the foundations of a great place to work. They are innovative and continuously improve by acquiring other organisations and developing their portfolios to strengthen their position in the worldwide market place. An action orientated and results driven organisation where teamwork and customer focus are high on the list of priorities
How to Apply
Click apply or contact Angela Barclay, Divisional Manager, Life Sciences on 02 8877 8743 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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