Medical Safety Manager – Ultrasound

This is a fully remote position, open to applicants in Massachusetts, +1 more state.

📋 Description

• Take charge of thorough evaluations of medical product safety independently, utilizing post-marketing surveillance, literature analysis, and clinical trial information.

• Recognize and evaluate potential risks and safety signals to enhance patient safety.

• Offer safety insights and advice for Health Hazard Evaluations, Risk-Benefit Analyses, and recall protocols.

• Contribute safety perspectives to New Product Introduction, clinical studies, and post-marketing initiatives.

• Collaborate on regulatory submissions and generate safety documentation, such as RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports.

• Address safety inquiries from healthcare professionals, patients, and internal parties.

• Assist in implementing safety policies, procedures, and programs that ensure compliance.

• Stay updated on changing medical product safety regulations and guidelines.

• Offer input on safety studies and vigilance activities throughout the lifecycle of products.

⛳️ Requirements

• A minimum of 5 years of experience with a bachelor’s degree, or at least 3 years of experience with a master’s degree or higher, in Medical/Clinical Affairs/Medical Safety within the Medical Device sector is strongly preferred.

• A bachelor’s/master’s degree or higher in Medical Science, Nursing, or a related field is required.

• Comprehensive understanding of pertinent medical device industry standards and regulations, including ISO and IEC.

• In-depth knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device context.

• Prior clinical experience at the bedside is preferred.

• Relevant specialized clinical experience is preferred.

• An MD or PhD is preferred.

• Certification as a Professional in Patient Safety (CPPS) is preferred.

• Exceptional communication skills and the capability to influence cross-functional stakeholders through clinical expertise and understanding of medical device standards and standard care.

• Must be able to fulfill minimum physical, cognitive, and environmental job requirements with or without accommodations.

• Authorization to work in the US is necessary; candidates needing current or future visa sponsorship will not be considered.

• Candidates must reside in or be within commuting distance of the specified locations.

🏝️ Benefits

• Generous paid time off (PTO).

• 401k plan with up to a 7% match.

• Health Savings Account (HSA) with company contributions.

• Employee stock purchase plan.

• Education reimbursement available.

• Potential for annual incentive bonuses, sales commissions, or long-term incentives.

• Comprehensive Philips Total Rewards benefits program.