Medical Safety Manager – Ultrasound

🕒 il y a 5 jours

🏈 Alabama, Alaska, +44 états de plus – Distant

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💵 $133 000 - $237 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 0%

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🗣️🇺🇸🇬🇧 Anglais requis

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Philips

10 000+ employés

🏥 Santé

🔧 Matériel

💰 Post-IPO Equity - Philips en 2025-03

Healthcare • Hardware

Philips est une entreprise mondiale de technologie de la santé (Koninklijke Philips N. V. ) qui développe des systèmes d'imagerie médicale (IRM, CT, échographie portable), des solutions de surveillance des patients et de soins critiques, ainsi que des produits de santé pour les consommateurs tels que Sonicare et l'application Pregnancy+. L'entreprise met l'accent sur la fourniture de solutions aidant les cliniciens à offrir des soins plus rapides et de meilleure qualité et propose également des produits de soins personnels et de santé bucco-dentaire axés sur le consommateur. Philips se positionne autour des équipements de santé, de l'informatique clinique et des soins connectés, ainsi que des technologies de santé destinées aux patients.

Description

• Independently oversee medical product safety surveillance activities • Analyze post-marketing surveillance, literature review, clinical trial, and real-world evidence data • Identify and assess potential risks and safety signals • Provide safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures • Support New Product Introduction, clinical studies, and post-marketing efforts • Provide safety input for regulatory submissions, RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports • Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders • Support implementation of safety policies, procedures, and programs • Monitor evolving medical product safety regulations and guidelines • Contribute to safety studies and vigilance activities throughout the product lifecycle • Work in a field-based role

🎯 Exigences

• 5+ years of experience with a bachelor’s degree, or 3+ years of experience with a master’s degree or higher, in Medical/Clinical Affairs/Medical Safety in the Medical Device industry • Bachelor’s/master’s degree or higher in Medical Science, Nursing or equivalent • Strong knowledge of relevant medical device industry standards and regulations, including ISO and IEC • Strong knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device environment • Prior bedside-related clinical experience preferred • MD/PhD preferred • Related specialized clinical experience preferred • Certified Professional in Patient Safety (CPPS) preferred • Excellent communication and ability to influence cross-functional stakeholders • Must successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation • US work authorization required; visa sponsorship unavailable • Must reside in or within commuting distance to posted locations

🏖️ Avantages

• Generous PTO • 401k with up to 7% match • HSA with company contribution • Stock purchase plan • Education reimbursement • Annual incentive bonus may be offered • Sales commission may be offered • Long-term incentives may be offered

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