The role of Senior Regulatory Affairs Specialist contributes to achieving Cochlear's business outcomes by providing regulatory support and guidance to help bring innovative products to our customers and helping ensure that Cochlear is compliant with premarket and post market regulatory requirements for all medical devices. This role will work closely with colleagues based at the legal manufacturers and colleagues located in North America. The Senior Regulatory Affairs Specialist will support , guide, and lead projects in order to meet the regional priorities.
Responsibilities
Ensure company business plans are met by submitting regulatory applications within agreed timelines. Be able to link the impact of Regulatory activities with other departments and proactively communicate and relevant information.
This may include facilitating conference calls and documenting all written correspondence and face to face meetings. Actively cultivate a good relationship with regulatory authority personnel.
Represent Regulatory on cross functional product launch teams and serve as subject matter expert and key contact.
Manage assigned post‐approval reporting obligations in the areas of progress reports for post‐approval studies and other conditions of approval. Support post market requirements related to CAPAs or field actions. Ensure documentation is kept up to date and that applicable procedures are followed.
Key Requirements
To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at intervie w:
Bachelor's Degree
Ideal candidate will possess an advanced degree in a scientific, technical, or engineering field
5+ years regulatory experience
Thorough knowledge of Health Canada and Food and Drug Administration requirements as they relate to Class II and Class III medical devices
Demonstrated analytical thinking skills to identify and resolve problems.
Demonstrated experience in the management, writing and compilation of a regulatory submission.
Benefits
In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.Pay Range in the United States : $1 20 ,000 - $1 30 ,000 based upon experience, as well as a n annual bonus opportunity of 7.5% of base salary . Exact compensation may vary based on skills, experience, and location.Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting , Paid Time Off, tuition reimbursement, maternity and paternity leave , Employee Stock Purchase Plan and pet insurance.Who are we?Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind - thinking about their needs.Physical & Mental DemandsHealth insuranceDental insuranceVision insurance401(k)Equity / stock optionsPerformance bonus
Additional Information
Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.
Senior Regulatory Affairs Specialist
Position Spotlight:
What you'll need: Minimum 5+ years of regulatory experience and a strong background in FDA submission writing
What you'll do: Help to develop, support, and execute regulatory strategies for all product lines
Location: Hybrid work environment operating out of our head office in Lone Tree, CO
Cochlear · Lone Tree, CO