Medical Safety Manager – Ultrasound

🕒 il y a 5 jours

🍂 Massachusetts, Washington – Distant

🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $133 000 - $237 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Philips

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare • Healthcare Insurance • Biotechnology

Au cours de la dernière décennie, nous nous sommes transformés pour devenir un leader centré sur les technologies de santé.

Description

• Independently oversee comprehensive medical product safety evaluations using post-marketing surveillance, literature reviews, and clinical trial data • Identify and assess potential risks and safety signals to support patient well-being • Provide safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures • Support New Product Introduction, clinical studies, and post-marketing activities with safety perspectives • Collaborate on regulatory submissions and prepare safety documentation, including RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports • Respond to safety inquiries from healthcare professionals, patients, and internal stakeholders • Support safety policies, procedures, and programs that promote compliance • Monitor evolving medical product safety regulations and guidelines • Provide input into safety studies and vigilance activities throughout the product lifecycle

🎯 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 strongly preferred • 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 • Related specialized clinical experience preferred • MD/PhD preferred • Certified Professional in Patient Safety (CPPS) preferred • Excellent communication and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards • Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation • US work authorization required; candidates requiring current or future visa sponsorship will not be considered • 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, sales commission or long-term incentives may be offered • Comprehensive Philips Total Rewards benefits program