Senior Medical Safety Lead, Cardiac Rhythm (Remote)

Medtronic plc; Minnesota; Remote; USD 130.000 - 196.000; Vollzeit

Benefits dieser Stelle

Health, Dental and Vision Insurance

Health Savings Account

Life Insurance

Tuition assistance/reimbursement

401(k) plan + employer match

Paid time off

Employee Stock Purchase Plan

Zusammenfassung

Medtronic in the United States seeks a Principal Medical Safety Specialist, Cardiac Rhythm Management, to oversee safety evaluations across CIED therapies and post-market activities. This role emphasizes collaboration with R&D, Quality, Regulatory, and Clinical teams and includes up to 10% travel.

You will assess safety signals, review literature and registries, provide input for safety reviews, risk assessments, and regulatory reporting, and lead initiatives to strengthen safety practices

Qualifikationen

• Bachelor's degree in Nursing or healthcare-related field with active licensure.
• 7+ years CIED management experience or 5+ years with an advanced degree.
• Experience in Medical Safety, Medical Affairs, Clinical Management, or related clinical functions.
• Knowledge of CIED therapy management and remote monitoring.
• Experience evaluating clinical, safety, or post-market data for risk-based decisions.
• For degrees earned outside the US, the degree must satisfy regulatory requirements.

Aufgaben

• Evaluate safety events, adverse event trends, and potential safety signals.
• Conduct medical safety assessments using literature, registries, and post-market data.
• Apply CIED expertise to safety evaluations across the product lifecycle.
• Respond to safety inquiries from internal stakeholders and regulatory agencies.
• Collaborate with cross-functional teams to address emerging safety concerns.
• Maintain expertise in therapies, literature, regulatory requirements, and industry standards.
• Provide evidence-based input to safety reviews, risk assessments, and regulatory reporting.
• Lead or support initiatives to improve safety practices and cross-functional decision-making.

Kenntnisse

CIED management experience

Risk-based decision making

Cross-functional collaboration

Clinical/medical safety expertise

Regulatory knowledge

Communication skills

Ausbildung

Nursing degree or healthcare-related degree

IBHRE certification

Tools

SmartSync

CareLink 2090

CareLink Encore

Statistical analysis software

MS Word

MS Excel

Jobbeschreibung

Medtronic in the United States seeks a Principal Medical Safety Specialist, Cardiac Rhythm Management, to oversee safety evaluations across CIED therapies and post-market activities. This role emphasizes collaboration with R&D, Quality, Regulatory, and Clinical teams and includes up to 10% travel.

You will assess safety signals, review literature and registries, provide input for safety reviews, risk assessments, and regulatory reporting, and lead initiatives to strengthen safety practices