Consultant, Medical Devices

1 week ago

Sydney, Australia Pharmalex Full time

**We are growing, grow with us**
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

**Consultant, Medical Devices**

**Your Job**
- We have an opportunity for a Consultant or Senior Consultant, Medical Devices to join our Medical Devices Regulatory and Quality Consulting team in Australia.
- In this role you will have the opportunity to work with a broad range of clients (primarily in Australia, USA and Europe) in the medical devices and diagnostics sectors.
- Your primary objective is to maximise client commercial success by ensuring appropriate premarket regulatory strategies, registrations, and regulatory compliance of client’s Medical Devices.
- As a Consultant you will manage several projects at once and competently resolve complex regulatory and technical issues.
- You will also gain exposure in the implementation and operation of PharmaLex’s Quality Management Systems. At times you will act as the authorized agent to coordinate and lead pre-submission meetings and other key meetings with the regulatory body.

**Your Profile**
- You have formal qualifications in science, engineering or similar field and a minimum of 5 years’ experience working in medical devices regulatory affairs and quality management either in the medical devices industry or a consulting setting.
- You have extensive hands-on experience in the preparation of regulatory and technical submissions preferably in a new product introduction setting for a range of jurisdictions (e.g. EU, ANZ, US, APAC) and with a strong track record of success.
- You are a natural problem-solver, commercially minded, a team player and exceptional with stakeholder management. You enjoy deep diving into technical material but at the same time you can effectively prioritise and manage several projects at once.
- You enjoy collaborating and it’s natural for you to share your knowledge with others.
- You are a professional with a thirst to learn and an open mind.

**We offer**
- By joining the PharmaLex Australia team you will become part of a team globally renowned as specialists in our field. Sharing knowledge and expertise with others is part of every day.
- We are a diverse workplace and welcome experiences from other countries and settings. Whilst we are serious about our business we don’t take ourselves too seriously and aim to create a fun team environment where all can thrive.
- The majority of our team is based in Sydney, Australia however we invite applicants from other parts of Australia. We support flexible, hybrid working arrangements.

For further information please don’t hesitate to contact us:
**Ms / Mr Brandenburg**
**Manager Human Resources Australia**

Agencies only by prior agreement for the specific job opportunity.

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