Norfolk, VA, 23509, USA
2 days ago
Medical Safety Director
**Medical Safety Director** The Medical Safety Director will pioneer comprehensive safety evaluations and risk management strategies, optimizing product efficacy and ensuring patient safety. By staying at the forefront of safety science and regulatory advancements, you will shape the future of medical innovation and empower our team through insightful training and knowledge sharing. **Your role:** + Ensures patient safety by offering medical expertise in Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit Analyses (RBA), and recall procedures. + Provides essential input into safety-related sections of regulatory submissions and pertinent documents, including protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CER). + Acts as a medical expert, offering safety insights for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) Initiatives. + Conducts comprehensive evaluations of safety information sourced from Post-Marketing Surveillance (PMS) and literature searches to ensure a thorough understanding of potential risks and benefits. + Provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product life cycle. + Contributes to the development and review of safety related documents, including risk management plans, safety reports, and regulatory submissions. **You are the right fit if:** + You have acquired 3+ years of experience in medical safety roles within the medical device industry, with hands-on experience with Health Hazard Evaluations (HHE), Issue Impact Assessments (IIA), Risk-Benefit Analyses (RBA), and Post-Market literature reviews. The ideal candidate has experience managing direct reports and providing technical guidance. + Your skills include a strong background and deep medical expertise in assessment of clinical risk-benefit throughout the product development life-cycle; deep knowledge and understanding of all applicable standards and regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc. Experience leading medical input into critical business decisions regarding potential patient safety issues. You can perform analysis and interpretation of signals & trends from multiple inputs including clinical data, literature, complaints etc. + You have an MD, MBChB, MBBS, DO or equivalent with 3+ years of direct medical safety experience in the medical device industry. Experience working at the bedside as a practicing clinician is also required. + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. + You are an excellent communicator (verbal and written) and have strong interpersonal skills as required for cross-functional collaboration. You have a proven ability to be a strong advocate for patient-centric decision making and are adept at anticipating changing priorities and demands to address them proactively. **How we work together** We believe that we are better together than we are apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is a field-based role. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we will not stop until everybody has access everywhere to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our commitment to diversity and inclusion. **Philips Transparency Details** The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, MT, NE, NM, OK, SC, SD, TN, UT, and WV are $156,750 to $250,800. The pay range for this position in AL, CO, FL, GA, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, and WY are $165,000 to $264,000. The pay range for this position in AK, DE, HI, MD, RI, and WA is $173,250 to $277,200. The pay range for this position in CA, CT, MA, NJ, NY, DC, is $184,800 to $295,680. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives, may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. **Additional Information** US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. \#LI-PH1 It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Equal Employment and Opportunity Employer/Disabled/Veteran
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