Sr Medical Affairs Spec

Sr Medical Affairs Spec
12 months contract
100% Remote – EST/CST Zone
Client Location: Miami Lakes office, Florida, 33014

HM's Top Needs:
1. 5 years VAD experience
2. Active medical license (RN/PA/NP, etc.)
3. Hands on patient care/bedside experience - within the past 10 years
Education Required: Education commensurate to earning a Medical License
Years’ Experience Required: MInimum 5 years

Senior Medical Safety Specialist supporting Mechanical Circulatory Support – Remote Option/Contingent with potential to full time.
Careers that Change Lives

We are seeking a Senior Medical Safety Specialist, a fully remote opportunity, medical expertise and assessment to support patient safety throughout the lifecycle as both an advocate for patient safety and in support of safe and effective use of H/LVAD devices. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical to help deliver aProductst our highest quality standards.
The Senior Medical Safety Specialist works with minimal supervision on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions, including Regulatory, Quality/Post-Market vigilance, Risk Management, Complaint Handling, Product Development, and Medical Affairs. They primarily interact with MS team members (Medical Safety Medical Directors and Specialists), and other functions as needed, to share information or Product input to support decision-making on various aspects of patient safety. They may occasionally interact in a supportive role with external physicians.
A Day in the Life
You will apply your medical knowledge, clinical bedside expertise, and product knowledge to promote patient safety through the following activities:
• Leverage medical knowledge and advocate for patient safety by providing input to internal functions and business processes across the product life cycle promoting product safety.
• Apply knowledge of HeartWare Ventricular Assist Device and/or Left Ventricular Assist Device (LVAD) management.
• 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 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.
• 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).
• 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.
• Acquire and maintain advanced knowledge of applicable business unit policies/procedures, 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 a matrixed organization.
• Develop solutions and lead opportunities to advance and improve safety practices.
• May lead other projects that span outside of Medical Safety, as assigned in part or in entirety.
• 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 various levels and audiences.
• Adapt verbal and written communication style to situational context.
• Adapt to changing priorities and work demands.
• Travel is required. Less than 10%.
Must Have: Minimum Requirements
• Bachelor’s degree required in Nursing or related healthcare field.
• Licensed healthcare professional in related healthcare field.
• Proficient knowledge of cardiac disease states managed by a mechanical pump.
• Combination of Licensure and Medical Affairs/Safety or Clinical Management experience.
• Proficient knowledge of (LVAD) including heart rhythm interpretation, device programming, failure modes and medical complications, and implant procedural workflow.
• Minium of 4 years of relevant LVAD management experience (including implant procedures, programming, and device management in a clinic or hospital setting) or advanced degree with minimum of 2 years of similar relevant experience.
Nice to Have
• Ability to perform patient assessments.
• 3+ years experience specifically in the medical device industry preferred.
• Ability to understand and apply practical medical and product knowledge in a competent manner for Medical Safety activities.
• Able to make competent, risk-based, and timely medical safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness.
• Able to understand scientific/technical concepts and function of medical devices.
• Excellent verbal and written communication skills to effectively convey message and influence diverse stakeholders.
• Versatile learner, able to quickly and effectively integrate new information and skills.
• Divergent thinker with solid critical thinking and problem-solving skills. Must be able to reach determined goals by prioritizing workload effectively and independently.
• High attention to detail and accuracy; able to work independently with minimal supervision; accountable for outcomes.
• Able to develop trusted relationships and collaborate with peers, co-workers, and key functional partners.
• 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.
• Command of basic statistical and data analytical assessments.