Senior Regulatory Affairs Specialist

Cochlear•Lone Tree, CO

8d•$120,000 - $130,000•Hybrid

About The Position

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.

Requirements

Minimum 5+ years of regulatory experience and a strong background in FDA submission writing
Bachelor’s Degree
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.

Nice To Haves

Ideal candidate will possess an advanced degree in a scientific, technical, or engineering field

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.
Independently write executive summaries and compile documents for submissions of all types for FDA and Health Canada.
Ensure that submissions and follow up activities are of high quality, leading to timely approvals.
As the main contact for your written submissions, liaise with health authorities as needed to meet project goals. 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.
Work with the Clinical Studies and Research & Development teams to secure approval for any studies requiring an Investigational Testing Authorization or Investigational Device Exemption.
Coordinate the creation of required progress reports and help ensure required reports are submitted on time.
Provide basic assistance with study design to ensure the study will meet the needs of regulators and lead to a successful marketing authorization.
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.