- 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.
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 growth.
professionals to join a leading employer in the industry during an exciting
period of sustained growth.
Responsibilities:
- 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 4-5 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
- Excellent communication skills – highly
articulate with ability to work with interdepartmental teams. - Ideally, exposure to chemicals, consumables or
cosmetics regulatory compliance
Remuneration:
Salary: $ Negotiable, plus Gym Membership, discounted products, Birthday Leave
and
more…
For more information or to apply contact Diarmuid on +61 8096 0060 / email your
application to dsexton@adroitpeople.com.au
Confidentiality Assured.
