Medical Safety Manager, Ambulatory Monitoring – Diagnostics

This is a fully remote position, open to applicants in Alabama, +45 more states.

📋 Description

• Conduct thorough safety evaluations independently utilizing post-marketing surveillance, literature reviews, and clinical trial data.

• Identify and evaluate potential risks and safety signals.

• Offer safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, risk management activities, and recall procedures.

• Assist in New Product Introduction, clinical studies, and post-marketing initiatives.

• Contribute safety input for regulatory submissions, RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports.

• Address safety-related inquiries from healthcare professionals, patients, and internal stakeholders.

• Aid in the implementation of safety policies, procedures, and programs.

• Monitor changes in medical product safety regulations and guidelines.

• Provide input into safety studies and vigilance activities throughout the product lifecycle.

• Operate in a field-based role outside the company’s primary facilities, typically at customer or supplier locations.

⛳️ Requirements

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

• Previous bedside clinical experience is required.

• Comprehensive understanding 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 context.

• Bachelor’s/master’s degree or higher in Medical Science, Nursing, or a related field.

• MD/PhD is highly preferred.

• Related specialized clinical experience is preferred.

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

• Ability to meet the minimum physical, cognitive, and environmental job requirements with or without accommodation.

• Exceptional communication skills and the ability to influence cross-functional stakeholders using clinical expertise and knowledge of care standards and medical device regulations.

• US work authorization is mandatory; candidates needing visa sponsorship now or in the future will not be considered.

• Must live in or within commuting distance of the designated locations.

🏝️ Benefits

• Annual incentive bonus may be available.

• Sales commission may be offered.

• Long-term incentives may be provided.

• Generous paid time off (PTO).

• 401k plan with up to 7% matching contribution.

• Health Savings Account (HSA) with company contribution.

• Stock purchase plan available.

• Education reimbursement opportunities.

• Company relocation benefits are not provided.