Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
This niche, small but very reputable medical device organisation, is looking for an experienced, professional Regulatory Affairs Manager. The primary responsibility of this position is to provide advice and direction to the business in relation to regulatory responsibilities for Australia and New Zealand and to have a solid understanding of medical device regulations associated with product development and the approval process. You will need a proven track record of management, compilation, submission and maintenance of regulatory filings.
You will manage the interactions with regulatory agencies (TGA, MedSafe) and external providers in order to meet designated timeframes and maintain regulatory compliance as well as have a solid understanding of business processes and how they interact with regulatory processes (product design and development, verification, validation, realization, distribution, quality, clinical trials, etc.). Your creativity, foresight and ability to provide input and impact analysis to activities of importance will be essential to the success of this role as will your demonstrated interpersonal and project management skills, analytical thinking skills to identify and resolve problems, ability to deal with pressure from a number of stakeholders and be able to work under tight deadlines.
You will have a minimum of three years’ experience in regulatory affairs in medical devices and hold a degree in either a science or health care discipline. You have built credible relationships with government authorities, industry bodies etc. and have been successful in negotiations and submissions of product portfolio registrations and processes.
Interested? Please 'apply now' quoting reference number 2403 or call Elizabeth Pettit or Rachel Tonkin on 02 9817 0599. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.
Additional Salary Information: + super
Internal Number: 2403
About Pettit Pharma & Device Search Pty Ltd
We offer a specialised recruitment service to the pharmaceutical, medical device and healthcare industries and their professionals. The healthcare, medical device and pharmaceutical industries seek extensive experience, in-depth expertise and the highest standards of professionalism. Pettit Pharma & Device Search is one of the leading pharmaceutical & medical device recruitment agencies in Australia, with a focus on finding the perfect match for both candidates and organisations. Our team of healthcare recruitment specialists cater to a broad range of roles from entry to director level in both Australia and throughout New Zealand.