Pharmaceutical & Medical Professionals, a Healthcare Professionals Group business is currently recruiting for a Regulatory Affair Manager

Our client, are a global medical devices manufacturer and a leader in their field who change lives on a daily basis to improve the health of patients around the world. A growing organisation with over 5000 employees globally and operations in over 100 countries in the world.

Pharmaceutical & Medical Professionals, a Healthcare Professionals Group business is currently recruiting for a Regulatory Affair Manager

About the Company

Our client, are a global medical devices manufacturer and a leader in their field who change lives on a daily basis to improve the health of patients around the world. A growing organisation with over 5000 employees globally and operations in over 100 countries in the world

About the opportunity

This role provides an opportunity to work with complex products supported by other team members who have strong and extensive longevity within the organisation. 

The key deliverables of the role are to:

  • Plan and coordinate regulatory strategies
  • Work closely with cross functional teams to assist in New Product Development
  • Close liaisons with regulatory bodies in order to create and submit technical files
  • Ensure compliance to global regulations for existing and new products alike
  • Approve labelling and marketing materials
  • Monitor internal and external standards
  • Provide post market regulatory support
  • Project manage any special projects as required 

Skills and experiences 

  • Strong engineering or regulatory background. Candidates from IP, legal, marketing backgrounds may also be considered
  • English or life sciences background with some exposure to a compliant environment
  • Stakeholder management
  • Project management  
  • Training experience with the ability to deliver in non-technical manner
  • Strong understanding of TGA, FDA, ISO13485
  • Strong attention to details
  • Negotiating and influencing skills
  • Good communication skills both orally and written

How to Apply

Click apply or contact Angela Barclay, Business Manager 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

 

Expertise Area Regulatory Affairs
Advertising Organisation Pharmaceutical & Medical Professionals, a Healthcare Professionals Group business
Hours Full Time
Link to Website http://www.hpgconnect.com/
Location(s) Sydney
State(s) New South Wales
Contact Name Angela Barclay
Phone 02 88778743
Email abarclay@hpgconnect.com
Last Date of Applications Wednesday, 1st of March 2017