Senior Specialist, Regulatory Affairs-Medical Devices

vor 2 Wochen

Sydney, Österreich Park Senior Villas Chandler Vollzeit

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 marketdevelopment and any action of effective product maintenance.

Regulatory Affairs Associate, Medical Devices

Location- Sydney- Australia (Applications are invited from candidates located in Australia with full working rights.)

Your Job
We have an opportunity for a Medical Devices Regulatory Affairs Associate to join our Medical Devices Consulting team based in Australia. The role title internally is Senior Specialist, Medical Devices. In this role you will have the opportunity to work on many different medical devices technologies, supporting a wide range of quality and regulatory activities. Your primary objective is to maximise client commercial success by ensuring appropriate licensing and regulatory compliance of client's products. In this role, you must be able to advise, support and manage multiple quality and regulatory projects in parallel, liaising with clients, peers and third party subject matter experts.

Your Profile

You have formal qualifications in science, engineering with 3 to 5 years' experience working in medical devices regulatory affairs either in industry or a consulting setting. Exposure to the full product lifecycle is a plus.
You have hands-on experience in the preparation of regulatory and technical submissions preferably with the TGA and a strong track record of success.
You have a can-do attitude, are a natural problem-solver, a team player with strong focus on results. You have good attention to detail and at the same time, can keep a focus on the big picture and goals. You can prioritise and manage several projects at once.
You have strong interpersonal skills and enjoy collaborating with colleagues and external stakeholders.

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 offer a range of flexible working options including part time, varying start and finish times and remote working. We are a diverse workplace and we aim to create a work environment where all can thrive.
Our head office is based in St Leonards, Sydney and whilst Sydney is our preferred candidate location we are open to considering candidates based in Brisbane, Adelaide, Canberra or Melbourne.

Applications are invited from candidates located in Australia with full working rights.

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiveyour application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don't hesitate to contact us:

Ms Jennie Brandenburg
Human Resources, Australia

Agencies only by prior agreement for the specific job opportunity.
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