Regulatory Affairs Specialist II

Regulatory Affairs Specialist IIChange people's lives and love what you do at Cochlear—the most recognized brand in hearing health care—helping people hear and be heard around the world, while being part of one of Denver Business Journal's 2026 Best Places to Work honorees in Denver. This is a fantastic opportunity to join the Regulatory Affairs team at the global leader in implantable hearing devices! In this role, you will be based in our Americas head office in Lone Tree, CO. This role is hybrid, requiring you to be in the office 3 days per week minimum, with 2 days per week working from home.The role of Regulatory Affairs Specialist II contributes to achieving Cochlear's business outcomes by helping to bring innovative products to our customers and helping ensure that Cochlear is compliant with premarket and post market regulatory requirements for all medical devices. The role of Regulatory Specialist II will work closely with colleagues based at the legal manufacturers and colleagues located in North America. The Regulatory Affairs Specialist II will write and assist in writing submissions for the Food and Drug Administration and Health Canada in order to meet the regional priorities.Key ResponsibilitiesWrite executive summaries, assemble documents, and assist in preparation and creation of regulatory submissions to FDA and Health Canada. Ensure company business goals are met by submitting regulatory applications within agreed timelines.Execute strategies for response to regulatory questions on significant submissions. For minor submissions, independently develop strategy for response.Work cross-functionally with regional colleagues and colleagues at the legal manufacturers to ensure alignment and agreement on answers to any questions.Identify, document and implement improved regional and global regulatory processesProvide initial or final documented assessment of any impacts of changes to devices, labeling, or manufacturing processes.Key RequirementsTo 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 interview:Bachelor's degree or equivalent work experience6+ Years of Experience working in regulatory affairs or a related field may be substituted for Bachelor's Degree or equivalent work experience1?3 Years in a regulatory role (medical devices, pharmaceuticals, etc.)Technical writing skillsIdeal candidate will have RAPS certificationKnowledge of Health Canada and Food and Drug Administration requirementsTotal RewardsPay Range in the United States: $90,000 - $95,000 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 tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives and working in an organization where they can be part of bringing the mission to life each day.Physical & Mental DemandsThe physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information. May be asked to occasionally transport/move up to 30 pounds, depending on the position. Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Influence, organization/classification of information and planning are also required.The work environment is an office environment. This is representative of the environment an individual may encounter while performing the essential functions of this job.