• Support Headway health plan partnerships and strategy • Promote external relations with Payers through presentations and sales meetings • Drive innovative data analyses to prove patient outcomes and generate insights • Develop understanding of digital tools for mental health clinicians • Collaborate with cross-functional teams including product, design, and operations • Be willing to travel

• Serve as the lead clinical liaison for partner providers across multiple regions, representing Cadence’s care model with clinical authority and consistency • Partner with PRMs on clinic visits and ongoing relationship management to strengthen long-term program engagement • Communicate the clinical rationale behind Cadence’s care protocols, data practices, and service offerings • Lead onboarding and training for new clinic partners • Resolve provider concerns with empathy, clinical judgment, and structured follow-through to deepen partner relationships • Translate field insights into actionable intelligence for clinical, product, and engineering teams, directly informing service improvements and care model refinement

Title: Director, Regulatory Affairs - Remote, Virginia, United States of America - Remote, France - Finland - Remote, Massachusetts, United States of America - Remote, Illinois, United States of America - Remote, North Carolina, United States of America - Remote, California, United States of America Full time Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide. You'll oversee regulatory post-market compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches. REQUIREMENTS: • Advanced Degree plus 8 years of experience, or Bachelor's Degree plus 10 years of experience in IVD/medical device regulatory affairs • Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field • Comprehensive knowledge of global regulatory requirements, particularly FDA as well as global health authorities ( e.g. Japan PMDA, China NMPA, Brazil ANVISA, Health Canada etc.) • Successful track record of regulatory submissions and agency interactions • Experienced in direct, professional, regulatory interactions with customers, pharma, and OEM business partners • Leadership experience managing and mentoring multi-site, multi-national teams • Experience in regulatory strategy development and implementation • Demonstrated expertise in regulatory compliance and quality management systems • Advanced project management and organizational skills • Excellent verbal and written communication abilities • Effective negotiation and influencing skills • Ability to work effectively in a matrix organization • Business acumen and strategic thinking capabilities • Proficiency in standard office technology and regulatory systems • Fluency in English required; additional language skills advantageous • Ability to travel 25-50% of time, including international • Knowledge of current industry trends and leadership participation in professional associations (e.g., TOPRA, RAPS, etc) Compensation and Benefits The salary range estimated for this position based in Virginia is $175,000.00–$219,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

• Assist the Chief Medical Director to direct and coordinate the medical management, quality improvement and credentialing functions for the business unit • Provides medical leadership of all for utilization management, cost containment, and medical quality improvement activities • Performs medical review activities pertaining to utilization review, quality assurance, and medical review of complex, controversial, or experimental medical services, ensuring timely and quality decision making • Supports effective implementation of performance improvement initiatives for capitated providers • Assists Chief Medical Director in planning and establishing goals and policies to improve quality and cost-effectiveness of care and service for members • Provides medical expertise in the operation of approved quality improvement and utilization management programs in accordance with regulatory, state, corporate, and accreditation requirements • Assists the Chief Medical Director in the functioning of the physician committees including committee structure, processes, and membership • Conduct regular rounds to assess and coordinate care for high-risk patients, collaborating with care management teams to optimize outcomes • Collaborates effectively with clinical teams, network providers, appeals team, medical and pharmacy consultants for reviewing complex cases and medical necessity appeals • Participates in provider network development and new market expansion as appropriate • Assists in the development and implementation of physician education with respect to clinical issues and policies • Identifies utilization review studies and evaluates adverse trends in utilization of medical services, unusual provider practice patterns, and adequacy of benefit/payment components • Identifies clinical quality improvement studies to assist in reducing unwarranted variation in clinical practice in order to improve the quality and cost of care • Interfaces with physicians and other providers in order to facilitate implementation of recommendations to providers that would improve utilization and health care quality • Reviews claims involving complex, controversial, or unusual or new services in order to determine medical necessity and appropriate payment • Develops alliances with the provider community through the development and implementation of the medical management programs • Represents the business unit before various publics both locally and nationally on medical philosophy, policies, and related issues • Represents the business unit at appropriate state committees and other ad hoc committees • May be required to work weekends and holidays in support of business operations, as needed