Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. FDA CDRH – Medical Officer (Plastic Surgeon) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and plastic surgery, as relevant to medical devices. Requirements and Qualifications - The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least ten (10) years of relevant clinical experience - Certification from a U.S. relevant specialty board organization, e.g., the American Board of Plastic Surgery (ABPS), etc. - Thorough understanding of current clinical practices in plastic surgery, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of plastic surgery (e.g., aesthetic and body contouring devices [liposuction systems, energy-based skin tighteners, lasers], precision cutting and dissection tools (e.g., electrosurgical units, dermatomes, skin graft meshers), microsurgical equipment (operating microscopes, micro-instruments, doppler ultrasound), breast and implant-related tools (tissue expanders, keller funnel), craniofacial and bone tools (piezoelectric bone scalpels, internal fixation systems) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems. - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred. - Ability to communicate well with others using excellent written and verbal communication skills. - Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel. This position is 100% telework. Must be a US Citizen or a Full Green Card holder. Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. FDA CDRH – Medical Officer (Medical Oncologist) SME Position Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and medical oncology, as relevant to medical devices. Requirements and Qualifications - The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least ten (10) years of relevant clinical experience - Certification from a U.S. relevant specialty board organization, e.g., certification in Medical Oncology by the American Board of Internal Medicine (ABIM), etc. - Thorough understanding of current clinical practices in medical oncology, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of oncology (e.g., treatment devices [infusion pumps, implantable venous access devices, aseptic formulation equipment] diagnostic and monitoring tools [imaging systems, biopsy tools, diagnostic sets, lab equipment], supportive and safety devices (oncology treatment chairs/beds, sterile processing equipment, defibrillators), advanced technologies (AI-based diagnostic software, interventional radiology tools). - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 864 – Hematology and Pathology, 21CFR Part 866 – Immunology and Microbiology), and guidances is preferred. - Ability to communicate well with others using excellent written and verbal communication skills. - Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel. This position is 100% telework. Must be a US Citizen or a Full Green Card holder. Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

• Conduct weekly multidisciplinary rounds with Midwest and West Coast care teams, reviewing patient goals, complex medical and social situations, and providing clinical oversight and outcome-improvement strategies. • Serve as the designated reviewer and triaging physician for COMPASS patient escalations as they enter the queue, applying clinical judgment to prioritize and direct AI-flagged cases to appropriate next steps. • Alternate monthly care delivery education sessions with co-Medical Lead, developing and facilitating case-based learning (e.g., SUD management, integrated behavioral health, heart failure, steroid-induced hyperglycemia, functional seizures) for CHWs, care coordinators, pharmacists, and therapists. • Provide asynchronous and synchronous clinical supervision to licensed therapists (LCSW/LMFT) and pharmacist teams, including time-sensitive escalations such as acutely suicidal or medically unstable patients. • Rotate on-call coverage with co-Medical Lead for rare after-hours urgent clinical escalations and questions from field teams. • Serve as the clinical dyad partner for regional operations leads, supporting market performance against quality, HEDIS, and outcomes OKRs. • Represent Waymark at regional and national meetings with health system and health plan physician leadership, including presentations to MCO and FQHC Chief Medical Officers on Waymark’s care model and COMPASS platform. • Maintain current knowledge of clinical best practices across primary care, integrated behavioral health, street medicine, and population health, and contribute to quarterly clinical guideline reviews.

At Hologic, we’re an innovative medical technology organization that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health What powers our growth across Breast & Skeletal Health, Diagnostics and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind. Hologic Oncology Services is seeking a field based Medical Science Liaison (MSL) responsible for bringing together and communicating the scientific and clinical benefits of the Hologic Oncology product portfolio to health care providers. A successful MSL understands and articulates at the highest clinical level all technical aspects of the products yet appreciates commercially what is necessary for the product to be fully implemented. Duties & Responsibilities: - Facilitate the exchange of medical and scientific data to a targeted audience including key opinion leaders (KOL's), physicians, and other health care providers regarding Hologic Oncology products via in-person or virtual presentations to increase awareness of products. - Support cross functional teams in initiatives such as faculty speaker training, sales training and review of promotional and educational materials. - Identifies and recommends potential participants of advisory boards, Medical Education speakers and other medical/scientific topics of mutual interest. - Participates in regional commercial training and strategy development meetings to assist in the building of a strong regional business unit. - Present technical content at regional speaking engagements (Roundtables, Grand Rounds, Tumor Boards, etc.) with physicians to broaden clinical understanding. - Maintains clinical, scientific, and technical expertise via attendance as directed at conferences, technical meetings and symposia, review of scientific journals and partnership with product and technology experts. - Conduct medical and scientific education and support for the field organization to increase Oncology presence and market awareness. - Travels within the assigned region to establish and maintain relationships within the clinical and scientific communities. The assigned region may adjust as necessary. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required: - Ability to work successfully in a team environment, and communicate regularly with other MSLs, sales management, marketing, and R&D to understand scientific/clinical information, business strategies, and market dynamics in order to execute the appropriate clinical discussions with customers - Ability to rapidly acquire knowledge of applicable disease states that are reflected by the use of Hologic Oncology products - Ability to rapidly acquire knowledge of the competitive landscape in the oncology diagnostics industry - Ability to communicate complex messages clearly - Excellent verbal and written communication skills, with experience writing and publishing materials for peer reviewed publications preferred - Excellent public speaking skills required - Excellent scientific analytical skills - Ability to integrate and apply feedback in a professional manner. Education: - Ph.D. in an applicable scientific discipline required; with post-doctoral fellowship training in a biomedical science discipline desired Experience: - One to three years clinical, medical or scientific experience within a medical device, biotechnology or pharmaceutical company Specialized Knowledge: - Oncology expertise and experience is preferred - Expertise in Microsoft Windows and Office, specifically Outlook, Word, and PowerPoint, Excel and other popular business software desirable Additional Details: - Work is performed in a home office, medical office and conference environments - Regularly required to travel up to 75% of the time, and may include overnight and weekend travel The annualized base salary range for this role is $128,700 to $201,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-AH1 #remote