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Senior Regulatory Affairs Specialist

Apply now Job no: 612408
Work type: Fixed Term Contract (Cochlear payrolled)
Location: Sydney
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.

Cochlear’s Regulatory Pipeline Strategy team leads the efforts to obtain and maintain regulatory approvals and licenses that allow us to bring our customers the outstanding products we develop and manufacture. We have an excellent opportunity for an experienced regulatory affairs professional to join our team as a Senior Regulator Affairs Specialist on an a full time or part time 18-month fixed-term contract based in Cochlear’s head office in Sydney.

Your key responsibilities will be:

  • Lead the development of global regulatory strategy for new implants by working closely with our regional and local regulatory affairs colleagues in determining local and regional regulatory requirements and options for regulatory submissions, approval pathways, and compliance activities;
  • Identify, interpret and champion regulatory requirements and guidelines, contribute technical knowledge, and provide regulatory input and technical guidance on global regulatory requirements to product development teams;
  • 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.

You bring your skills and experience.

  • Bachelors or master’s degree in science or engineering, legal, scientific or healthcare;
  • 3+ years experience in regulatory affairs including track record of management, compilation, submission and maintenance of regulatory filings;
  • Able to identify, assess and apply regulatory intelligence (e.g. standard, guidelines and directives) to develop global regulatory strategies;
  • Regulatory Affairs Certification (RAC) highly desirable
  • Demonstrated interpersonal, communication and relationship building skills,
  • Able to analyse and clearly convey complex information to peers, supervisors and other stakeholders;
  • Excellent report writing and documentation skills and strong skills in influencing in a matrix team environment;
  • Able to manage stakeholders at all levels within the business, build and leverage relationships and work collaboratively in cross-functional teams;
  • Able to make judgments and provide advice which balances the business interest and regulatory risk.

Cochlear Summary

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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