Medical Safety Manager – Image-Guided Therapy Devices

Job not on LinkedIn

🔥 1 minute ago

🏈 Alabama, Alaska, +44 more states – Remote

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💵 $133k - $237k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

😶‍🌫️ Therapist

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Philips

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Philips is a global health technology company committed to improving people's health and well-being through meaningful innovation. They focus on various domains including personal health, diagnosis and treatment, and connected care, striving to provide advanced technologies and solutions that enhance health outcomes for individuals and healthcare providers alike.

📋 Description

• Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance and literature searches • Support Risk Management, Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures • Provide safety perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts • Provide safety inputs for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports • Conduct literature reviews and surveillance activities to identify emerging safety issues • Answer safety-related inquiries from healthcare professionals, patients, and internal stakeholders • Contribute to safety-related policies, procedures, and programs • Monitor evolving medical product safety regulations and guidelines for compliance • Provide input into safety studies and medical device vigilance activities • Analyze clinical trial and post-market surveillance data to identify safety signals and trends • Work in a field-based role outside the company’s main facilities, generally at customer or supplier locations

🎯 Requirements

• 5+ years of experience with a Bachelor’s degree OR minimum 3+ years of experience with a Master’s degree • Experience in Medical/Clinical Affairs in the Medical Device/Biotech industry or equivalent • Experience as a clinician is required • Experience with Image Guided Therapy Devices preferred • Bachelor’s/Master’s degree in Medical, Nursing, or equivalent • MD preferred • 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 • Ability to perform minimum physical, cognitive, and environmental job requirements with or without accommodation • Excellent communication 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 current or future visa sponsorship will not be considered

🏖️ Benefits

• 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 • Philips Total Rewards benefits program • Company relocation benefits will not be provided

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