Regulatory Affairs Associate (Sydney)

  • Diverse Product Portfolio 
  • Great Working Environment 
  • Excellent Personal & Professional Development Opportunities

Our client is at the forefront of the medical device industry with operations nationwide and internationally. We are currently seeking an experienced Regulatory Affairs Associate to join the Regulatory Affairs Team at our client’s Sydney based operations to provide high level regulatory support for a diverse portfolio of products and pipeline developments.

This is an excellent opportunity for career-minded professionals to join a leading employer in the industry during an exciting period of sustained regional growth.

Duties:

  • In brief the successful applicant will be responsible for providing regulatory support to existing products within the company’s product portfolio, covering class I, II & III devices.
  • Providing advice on the interpretation of regulatory legislation and licence conditions for medical devices across the ANZ region.
  • Preparing high quality regulatory submissions related to all aspects of product development and post market technical file compliance auditing
  • Working across cross-functional team to ensure customer satisfaction and regulatory compliance for sales and promotional materials.

Requirements:

  • B.Sc. plus min 3-7 years’ regulatory experience, at least 1-2 years within medical technologies and/or diagnostics.
  • An accomplished professional with a track record of successful planning and preparation of regulatory submissions within medical technology environment.
  • Strong knowledge of ISO13485 requirements preferred.
  • Excellent communication skills – highly articulate with ability to work with interdepartmental teams.

Remuneration:

Salary: $ Negotiable, plus Gym Membership, Salary Packaging, discounted products, Birthday Leave and more…

Call Diarmuid on 02-8096 0060 / dsexton@adroitpeople.com.au.


Alternatively, you can register your CV directly to our database:

About Diarmuid Sexton

Diarmuid is Adroit People’s Managing Director and HR Practice Leader. Since 2001 Diarmuid has worked with clients in the medical device, pharmaceutical, legal and ICT sectors in Europe, Asia, Australia and the US providing strategic HR, recruitment and outplacement support.

His experience ranges from workforce planning to executive search, performance management and redundancy / career transition across technical, legal and commercial disciplines.

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