Senior Regulatory Affairs Specialist
Job no: 612408
Work type: Fixed Term Contract (Cochlear payrolled)
Categories: Quality & Regulatory, Oceania, Individual Contributor
Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference in people’s lives.
The Regulatory Pipeline Strategy team leads Cochlear’s efforts to obtain and maintain global regulatory approvals and licenses that allow us to deliver the outstanding products we develop and manufacture to our customers.
We have an excellent opportunity for an experienced regulatory affairs professional to join our Regulatory Pipeline Strategy team as a Senior Regulator Affairs Specialist on a full time or part time 18-month fixed-term contract based in Cochlear’s head office in Sydney.
In this role, you will develop and apply knowledge of regulatory requirements for key jurisdictions including US FDA, EU-MDR, and Australian TGA, and leverage your technical expertise and experience in the design and development or manufacturing of our products as you work with our colleagues in D&D, Clinical, Manufacturing, and Regional Regulatory Affairs to develop and execute regulatory strategies for our products.
You will be part of a collaborative local team, reporting to a manager, also based in Sydney, who is flexible, and supports development and growth.
Your key responsibilities will be to:
- Lead Global Regulatory Strategy development for new products by working with our regional regulatory affairs colleagues to understanding local and regional regulatory requirements and create options for regulatory submissions, approval pathways, and compliance activities;
- Provide input and guidance to R&D and Global Marketing teams regarding global regulatory requirements, to inform product development and launch strategies;
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable regulations;
- Adapt or create technical dossiers appropriate for the regional market submissions, coordinating support for regional regulatory affairs in working with regulatory authorities;
- Evaluate proposed product, labelling and manufacturing changes for regulatory filing solutions.
- Assess and identify regulatory filing requirements for proposed or planned product, labelling and manufacturing changes
Bring your skills and experience.
- Bachelors or master’s degree in science or engineering, legal, scientific or healthcare discipline;
- 3-5 years Regulatory experience in a design, manufacturing, sales & marketing, or consulting setting, including track record of management, compilation, submission and maintenance of regulatory filings (ideally for medical devices or Pharmaceuticals, but Consumer also considered).
- Understand medical device regulations associated with product development and approval in key markets, including US, European Union, and Australia
- Regulatory Affairs Certification (RAC) highly desirable
- Demonstrated interpersonal, communication and relationship building skills, enabling you to manage stakeholders at all levels within the business, build and leverage relationships and work collaboratively in cross-functional teams;
- Able to analyse and clearly convey complex information to peers, supervisors and other stakeholders;
- Experience in project management, where you have been accountable for delivering results within defined timeframes
- Able to make judgments and provide advice which balances the business interest and regulatory risk.
- Be motivated by achieving goals and meeting timelines in a fast-paced and highly technical environment, where you can feel proud that the work you do helps more people around the world to hear again and live full lives.
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Advertised: AUS Eastern Daylight Time
Anticpated Application Closing: AUS Eastern Daylight Time
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