Regulatory Affairs Manager – Medical Devices (The position has been filled)
Australia, Victoria
Full Time
01/03/2018
  • Permanent Full Time Role with ASX listed Australian Company
  • Professional, Friendly and Supportive Work Environment
  • Growing Company, Excellent Culture and Facilities, including onsite Parking

 

CLIENT

Our client is an established company within the medical product category, and operates its manufacturing operation in Melbourne, Australia. Their products are Sold, Marketed and Distributed around the globe, including market leadership position in some existing markets. With a very clear purpose and vision, product pipeline and significant regulatory approvals expected in their developing markets, this company is set for significant growth.

Investment in new facilities has been very recently completed with some regulatory approvals already granted, and the remaining imminent. Manufacturing core products from this facility will significantly improve cost, quality & consistency, and support the sales growth projection in untapped markets.

 

ROLE

This important role will contribute to the management of regulatory affairs for a variety of the Company’s medical device development programs.

You will ensure that projects are delivered in full, and on time, including all requisite activities including development of structure and content for all technical documentation, to ensure submission to; and acceptance by; various global regulatory bodies.

The ideal candidate will have medical device regulatory experience as well as having experience in direct interactions with global regulatory authorities, including TGA, FDA and EMA. Electronic submissions experience is highly desirable.

As the successful candidate, you will be able to balance the strategic demands of regulatory affairs within the commercial landscape. You will have a high degree of initiative and will be able to operate with a high degree of autonomy, exhibiting clear thinking and sound judgement.

Interpersonal communication skills will be paramount for this challenging role, including excellent written communication, due to the highly technical nature of the industry and the interaction with various regulatory agencies and commercial partners.

 

REQUIREMENTS

To be successful you will have a ‘can do’ attitude, proven track record and ability to be part of a champion team.

A summary of required criteria include:

  • Minimum of a BSc in Biochemistry, Pharmacology or other similar areas
  • A minimum of five years’ previous experience in Regulatory Affairs including dossier writing and preparation of regulatory submissions, preferably with Medical Devices
  • Experience in dealing with Australian, EU & US regulatory authorities in the medical device/pharmaceutical sector
  • Development and execution of regulatory strategies, including project planning and implementation
  • MUST have a good eye for detail, superior written communication skills, be a good team player and a problem solver
  • Ability to identify, analyse and manage risks associated within areas of responsibility and expertise

APPLICATIONS

To discuss this excellent opportunity please call our team on 03 9516 0100. After hours, please feel free to call Helen on 0438 620 434. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

 

 

THANK YOU

Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.