Senior Regulatory Affairs Specialist

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

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 pre‑market 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.

• 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 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.
• Facilitate conference calls, document all written correspondence and face‑to‑face meetings, and actively cultivate a good relationship with regulatory authority personnel.
• Work with the Clinical Studies and Research & Development teams to secure approval for 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 applicable procedures are followed.

• Bachelor’s Degree
• Advanced degree in a scientific, technical, or engineering field (ideal)
• 5+ years regulatory experience
• Thorough knowledge of Health Canada and FDA 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

• Pay Range in the United States: $120,000–$130,000 based upon experience, as well as an 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.

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. For this reason, our products, services and support will continue to evolve and improve. We are by our customers’ side through the entire hearing journey, so they can experience a life full of hearing.

Our employees say the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives and to be part of bringing the mission to life each day.

The physical and mental demands described below are representative of those that must be…