Medical Safety Officer (Medical Device)

Job Title:

Medical Safety Officer Job Description The Medical Safety Officer will serve as the clinical safety and risk management lead for medical device technologies across the full product lifecycle. In this contract role, you will ensure that products are safe, compliant, and supported by robust, focused safety evidence from development through post‑market surveillance. You will build and maintain a medical harms evidence base, lead risk management activities, and generate high‑quality safety evidence that supports regulatory clearance, ongoing surveillance, and market adoption. This is a remote position with an expected travel requirement of approximately 10-20%. Responsibilities Lead medical safety and risk management activities to establish safety performance criteria, clinical risk profiles, and benefit-risk assessments in alignment with ISO standards and relevant regulatory guidelines. Design and conduct systematic literature reviews and critical appraisals focused on adverse events, complications, and procedure- or device‑related harms to support risk assessments, clinical evaluation reports, labeling, and safety‑related product claims. Establish, structure, and maintain a comprehensive clinical and medical harms evidence library for relevant disease states, procedures, and device categories, including known adverse events, occurrence rates, and severity classifications. Develop, implement, and govern standardized coding frameworks (such as event type, seriousness, relatedness, and severity) to support consistent classification, trending, and medical evaluation of post‑market safety data. Collaborate closely with Research and Development, Regulatory Affairs, Quality, and Marketing to integrate clinical safety and risk management strategies into product design, labeling (including warnings, precautions, and contraindications), and commercialization plans. Partner with Post‑Market Surveillance, Medical Affairs, and Quality teams to monitor real‑world safety data, including complaints, vigilance reports, and registries, to support safety signal detection and contribute to corrective and preventive actions and Field Safety Corrective Actions when needed. Monitor competitor activities and the broader regulatory landscape to identify emerging safety issues, evolving expectations for risk management, and ongoing clinical studies relevant to device safety and harms. Clearly communicate safety assessments, benefit-risk rationales, and key findings to internal stakeholders and, when appropriate, to notified bodies, the FDA, and other regulatory agencies. Support the development and delivery of safety, health, and compliance training related to medical device risk management and safety processes. Ensure that all safety and risk management activities align with Good Clinical Practice and applicable regulatory and quality requirements. Essential Skills Medical degree (MD or MD/PhD) with prior experience as a practicing physician in the United States. Minimum of 5 years of experience in clinical safety, risk management, and clinical research within the medical device industry. Demonstrated expertise in clinical safety and risk management for medical devices, including familiarity with ISO standards relevant to risk management. Strong understanding of clinical evaluation requirements, including EU MDR and FDA expectations. Knowledge of Good Clinical Practice (GCP) and related regulatory guidance. Clinical domain expertise in breast cancer procedures, interventional oncology procedures, and medical devices used in cancer diagnostics. Proven ability to design and interpret benefit-risk assessments and clinical risk profiles. Experience working cross‑functionally with R D, Regulatory Affairs, Quality, Marketing, Post‑Market Surveillance, and Medical Affairs teams. Strong written and verbal communication skills, with the ability to clearly present safety assessments and benefit-risk rationales to both internal and external stakeholders. Ability to conduct and critically appraise medical and scientific literature focused on adverse events and safety outcomes. Additional Skills & Qualifications Strong knowledge of biostatistics as applied to safety endpoints and adverse event analysis. Proficiency with statistical tools such as STATA and SAS for safety data analysis. Experience conducting systematic literature reviews (for example, using PRISMA methodology) and synthesizing harms‑focused evidence. Experience generating background event rates and comparative safety analyses versus standard of care. Familiarity with safety coding frameworks for classifying seriousness, relatedness, and severity of events. Experience supporting regulatory submissions and interactions related to medical device safety and risk management. Ability to develop and maintain structured evidence libraries for clinical and medical harms data. Strong organizational skills and attention to detail in managing complex safety documentation and evidence bases. Comfort working in a remote, cross‑functional environment with teams distributed across locations. Work Environment This position operates in a remote work environment, providing flexibility in daily work location while maintaining close virtual collaboration with cross‑functional teams in R D, Regulatory Affairs, Quality, Marketing, Post‑Market Surveillance, and Medical Affairs. The role involves frequent use of digital collaboration tools, literature databases, and statistical software such as STATA and SAS to analyze safety data and manage evidence libraries. Travel of approximately 10-20% may be required for in‑person meetings, cross‑functional workshops, or regulatory interactions. The work focuses on medical devices in oncology and cancer diagnostics and emphasizes a culture of patient safety, regulatory compliance, and evidence‑based decision‑making. Job Type & Location This is a Contract position based out of Marlborough, MA. Pay and Benefits The pay range for this position is $300.00 - $300.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.

Application Deadline This position is anticipated to close on Apr 29, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.