Medical Safety Manager, Ambulatory Monitoring – Diagnostics

🔥 il y a 13 heures

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

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💵 $133 000 - $237 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

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Philips

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 conduct comprehensive safety evaluations using post-marketing surveillance, literature reviews, and clinical trial data • Identify and assess potential risks and safety signals • Provide safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, risk management activities, 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 • Provide input into safety studies and vigilance activities throughout the product lifecycle • Work in a field-based role outside the company’s main facilities, generally at customer or supplier locations

🎯 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 • Prior bedside related clinical experience required • 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 • Bachelor’s/master’s degree or higher in Medical Science, Nursing, or equivalent • MD/PhD strongly preferred • Related specialized clinical experience preferred • Certified Professional in Patient Safety (CPPS) preferred • Ability to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation • Excellent communication skills and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards • US work authorization required; candidates requiring visa sponsorship now or in the future will not be considered • Must reside in or within commuting distance to the posted locations

🏖️ Avantages

• Annual incentive bonus may be offered • Sales commission may be offered • Long-term incentives may be offered • Generous PTO • 401k with up to 7% match • HSA with company contribution • Stock purchase plan • Education reimbursement • Company relocation benefits will not be provided

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