Regulatory Affairs Specialist II

Cochlear · United States

Change people’s lives and love what you do! Cochlear is the most recognized brand in hearing health care. Regulatory Affairs Specialist II About the role Change 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 Responsibilities

• Write 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 processes
• Provide initial or final documented assessment of any impacts of changes to devices, labeling, or manufacturing processes.

• Bachelor’s degree or equivalent work experience
• 6+ Years of Experience working in regulatory affairs or a related field may be substituted for Bachelor’s Degree or equivalent work experience
• 1‐3 Years in a regulatory role (medical devices, pharmaceuticals, etc.)
• Technical writing skills
• Ideal candidate will have RAPS certification
• Knowledge of Health Canada and Food and Drug Administration requirements

• Pay 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.