[Hiring] Principal Medical Safety Specialist @Medtronic

Role Description The Principal Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle. This role is recognized as a subject matter expert, managing large projects or processes. The Principal Medical Safety Specialist reviews and delegates work to others when necessary and provides mentoring and coaching to lower-level specialists. Additionally, this role finds solutions to difficult, moderately complex issues and works with minimal manager supervision. The position is responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical. You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of:

• Medical Input:
• Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
• Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined.
• Medical Safety Assessments:
• Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.
• Author high quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
• Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action.
• Assist with obtaining input from external medical and subject matter experts on safety matters.
• Complete qualitative and quantitative assessments of post market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports.
• Safety Inquiries:
• Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations).
• Product and Therapy Knowledge:
• Acquire and maintain proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e., hazards and harms).
• Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies.
• Business Acumen:
• Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems).
• Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post market vigilance).
• Work effectively across the matrix.
• Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or in entirety that span outside of Medical Safety.
• Medical Communication and Influence:
• Lead and influence evidence-based medical decision making across the matrix organization.
• Provide strategic input and influence business strategies to optimize Medical Safety value.
• Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences.
• Adapt verbal and written communication style to situational context.
• Adapt to changing priorities and work demands.

Note: There will be up to 10% travel for this position.

Qualifications

• 7+ years of clinical experience (5+ years with an advanced degree).
• Active healthcare license with clinical knowledge and relevant patient care experience.
• Bachelor’s degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field).

Requirements

• Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial and/or spinal surgical specialty experience.
• Excellent verbal and written English communication skills.
• Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
• Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.

Benefits

• Competitive Salary and flexible Benefits Package.
• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Incentive plans.
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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