Principal Medical Safety Specialist - CRMDx
About The Position
The Principal Medical Safety Specialist provides medical and clinical safety expertise across the total product lifecycle for cardiology and electrophysiology products and therapies. The role assesses 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, the specialist partners with the Medical Director and cross-functional teams in Quality, Regulatory, Clinical, R&D, Medical Affairs, and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions. This position uses a hybrid work model, with employees required to work in a local office at least three days per week. The listed additional locations are Arden Hills, Minnesota, and Marlborough, Massachusetts. Visa sponsorship and relocation assistance are not available for this position.
Requirements
- Bachelor's degree in health care, life sciences, or a related field.
- Active professional licensure as a registered nurse (RN), advanced practice registered nurse/nurse practitioner (APRN/NP), or physician assistant (PA), as applicable.
- At least 5 years of direct patient care experience, including at least 2 years of experience in cardiology and/or electrophysiology with advanced CIED interrogation and troubleshooting experience.
- Strong clinical judgment and analytical skills, including the ability to interpret complex medical, scientific, and product performance information.
- 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, including the ability to communicate complex clinical and safety information clearly.
- Ability to build effective cross-functional relationships and influence without formal authority.
Nice To Haves
- Recent experience in a field-based clinical role providing clinical and technical support for CIED implant procedures.
- Advanced experience with cardiac rhythm management (CRM) technologies, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, subcutaneous implantable cardioverter-defibrillator (S-ICD) systems, leadless pacing systems, cardiac monitoring systems, and device interrogation and troubleshooting.
- At least 2 years of experience in Medical Safety, Clinical Research, Clinical Quality, or a related medical device function.
- Experience with safety signal evaluation, risk management, post-market surveillance, quality investigations, and/or benefit-risk assessments.
- Working knowledge of global medical device regulations and requirements.
- Experience working within a regulated medical device quality system and across multidisciplinary teams.
Responsibilities
- 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, electrophysiology, and cardiac implantable electronic devices (CIEDs) 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 evaluation of complex or emerging safety signals, trends, and product performance concerns; provide clinical assessments and recommend 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.
- 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.
Benefits
- Core and optional employee benefits are offered; details are referenced at www.bscbenefitsconnect.com.
- Exempt, non-sales roles may be eligible for an annual bonus target and long-term incentives, subject to plan eligibility and other requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
