Senior Director, Regulatory Affairs

Job description

**Overview:** The Senior Director, Regulatory Affairs is responsible for leading the global regulatory strategy for the company's portfolio of innovative spine and orthopedic products, including medical devices, biologics, combination products, and pipeline technologies. This leader will develop and execute regulatory strategies that support product development, global registrations, lifecycle management, and commercial growth while ensuring compliance with applicable regulations. Reporting to the Chief Operating Officer, the Senior Director will serve as the regulatory subject matter expert and strategic business partner, collaborating closely with Clinical Affairs, Quality Assurance, Research & Development, Operations, Medical Affairs, Marketing, and Executive Leadership. This individual will represent the company before global regulatory authorities and play a key role in advancing innovative therapies to improve patient outcomes. This full-time position is based on-site in Alpharetta, GA and requires approximately 20-30% domestic and international travel. **Key Responsibilities:** **Regulatory Strategy and Submission** - Develop and execute global regulatory strategies that support product development, clinical studies, product registrations, and commercialization. - Lead regulatory planning for new product development from concept through commercialization. - Provide strategic regulatory guidance for product changes, design modifications, manufacturing changes, and lifecycle management activities. - Evaluate regulatory risks and provide practical recommendations that align with business objectives. - Serve as regulatory representative on cross-functional product development teams. - Lead preparation, review, and submission of regulatory filings including: 510(k), PMA, De Novo, IDE, Technical Documentation, Design Dossiers, International product registrations, Regulatory responses and supplements. - Oversee regulatory submissions for product changes, labeling updates, manufacturing transfers, and renewals. **Regulatory Compliance** - Ensure ongoing compliance with global regulatory requirements throughout the product lifecycle. - Interpret evolving regulations and communicate business impact to executive leadership. - Support internal audits and external regulatory inspections. - Maintain regulatory procedures and ensure alignment with Quality Management System requirements. **Clinical & Product Development Support** - Partner with Clinical Affairs on regulatory aspects of clinical study design. - Review clinical protocols, investigator brochures, informed consent documents, and clinical reports. - Provide regulatory input for post-market clinical follow-up activities. - Support evidence generation strategies for reimbursement and commercialization. **Leadership** - Build, mentor, and develop a high-performing Regulatory Affairs team. - Establish department goals, metrics, and operating procedures. - Manage external regulatory consultants and contract resources. - Develop departmental budgets and resource plans. - Foster a collaborative, solutions-oriented culture across the organization. **Qualifications:** - **Education:** - Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Biology, Life Sciences, or related scientific discipline required. - Master's degree or PhD preferred. - RAC (Regulatory Affairs Certification) preferred. - **Experience:** - Minimum 12 years of progressive Regulatory Affairs experience within the medical device, biotechnology, or orthopedic industry. - Minimum 5 years of leadership experience managing regulatory professionals. - Demonstrated experience supporting Class II and Class III medical devices. - Experience with biologics and combination products is strongly preferred. - Experience leading FDA submissions: 510(k), PMA, IDE, and De Novo pathways. - Strong knowledge of MDR (EU 2017/745) and global regulatory frameworks. - Experience supporting commercial-stage products and new product development. **Travel Requirement:** - Approximately 20-30% domestic and international travel as required **Physical Requirements and Work Conditions** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. - **Mobility & Posture**: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping. - **Lifting/Carrying**: May require lifting and carrying items 50 pounds or more, depending on the role. - **Manual Dexterity**: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment. - **Driving**: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license. *Specific requirements may vary by role. Contact an HR representative for details related to the position.* **Our credentials** Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team. To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing. - Listing on the **SIX Swiss Exchange**under the symbol KURN since 2016 - A commercial & research footprint that spans **>20 markets** - Dozens of clinical and scientific expert Advisers - **>25**orthobiologics-related **patents** - **>400 patients evaluated**in Level I, randomized controlled clinical trials - **>20**well-controlled **Level I-IV clinical trials initiated**, including 6 that are complete1 - Published Level I evidence published in ***Spine*** *Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.* Kuros *Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice [here.](https://kurosbio.com/privacy-policy/)*