Principal Medical Safety Specialist

Gateway Recruiting; Minneapolis (MN); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

Gateway Recruiting seeks a Principal Medical Safety Specialist to oversee medical review of adverse events across cardiology products. You will provide expert safety assessments, evaluate signals, and guide risk management decisions throughout the product lifecycle.

Collaborating with Medical Director and Quality, Regulatory, Clinical, and R&D teams, you will ensure accurate safety communications and compliance with global regulations, while supporting CAPAs and post-market surveillance.

Qualifications

• Bachelor's or advanced degree in health care, life sciences or related field.
• Active, unencumbered professional licensure as RN, DNP or PA.
• 5+ years direct patient care, 3+ years cardiac lab experience.
• Proven ability to work independently and autonomously.
• Strong clinical judgment and analytical skills.
• Excellent writing and verbal communication skills.
• Ability to lead cross-functional work with minimal supervision.

Responsabilités

• Serve as a Medical Safety subject matter expert on cross-functional teams.
• Apply advanced clinical knowledge of cardiology to assess device safety and performance.
• Review adverse events from trials, post-market data, MDRs and other sources.
• Lead evaluation of complex safety signals and recommend risk mitigation.
• Provide medical input for CAPAs, PIRs and other quality systems.
• Analyze data and communicate concise safety assessments to leadership.
• Maintain knowledge of products, labeling, indications and safety profiles.
• Provide input for risk management documentation and IFUs.
• Review promotional and educational materials for medical accuracy.
• Identify opportunities to improve Medical Safety processes.
• Apply global device regulations and reporting requirements.

Connaissances

Clinical judgment

Analytical skills

Written communication

Cross-functional collaboration

Independent work

Formation

Healthcare degree

Outils

Microsoft 365

Description du poste

About the role:

The Principal Medical Safety Specialist is a health care professional responsible for the medical review of adverse event data across a range of products and disease states in cardiology. This individual completes accurate, timely and consistent medical assessments of adverse events and potential adverse events to provide medical expertise and objective oversight and help ensure safety vigilance throughout the total product lifecycle.

This role performs medical assessments of adverse events, evaluates emerging safety signals and product performance trends, and provides clinical input into risk management, post-market surveillance and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions.

Responsibilities will include:

• Serve as a Medical Safety subject matter expert on cross-functional teams supporting product development, risk management, post-market surveillance, quality investigations and remediation activities.
• Apply advanced clinical and technical knowledge of cardiology to assess device safety, product performance and potential patient impact.
• Perform medical review and assessment of adverse events and potential adverse events from clinical trials, post-market complaints, Medical Device Reports (MDRs) and other relevant data sources.
• Lead the evaluation of complex or emerging safety signals, trends and product performance concerns, providing clinical assessments and recommending appropriate escalation or risk mitigation.
• Provide medical expertise for complaint review boards, corrective and preventive actions (CAPAs), nonconforming event processes (NCEPs), product investigation reports (PIRs) and other applicable quality system processes.
• Analyze data from multiple sources and communicate concise, clinically meaningful safety assessments and recommendations to the Medical Director, cross-functional teams and leadership.
• Acquire and maintain proficient knowledge of assigned products and therapies, including device design and function, product labeling, indications, mechanisms of action, care pathways and overall safety profiles, including hazards and harms.
• Provide medical review and input for risk management documentation, labeling, instructions for use (IFUs), product safety communications, post-market surveillance and regulatory deliverables.
• Review promotional, educational and sales training materials for medical and clinical accuracy, as applicable.
• Identify opportunities to improve Medical Safety processes and practices.
• Apply knowledge of applicable global medical device regulations, standards and reporting requirements.

Qualifications:

Required qualifications:

• Bachelor's or advanced degree in health care, life sciences or related field.
• Active, unencumbered professional licensure as a registered nurse (RN), Doctor of Nursing practice (DNP) or physician assistant (PA).
• Minimum of 5 years of direct patient care experience, including a minimum of 3 years of cardiac lab experience.
• Experience with Microsoft 365.
• Proven ability to work independently and autonomously.
• Strong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance information.
• Demonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervision.
• Excellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety information.
• Demonstrated ability to build effective cross-functional relationships and influence without formal authority.

Preferred qualifications:

• Minimum of 2 years of related experience in Medical Safety within the medical device industry, Risk Management, Clinical Research and/or Clinical Quality.
• Recent industry experience.
• Medical device experience.