Principal Medical Safety (Ms) Specialist (Remote)

At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title:Principal Medical Safety
Location: Remote within the U.S.
Travel up to: 25%
A Day in the Life
The Sr Medical Safety (MS) Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle as both an advocate for patient safety and in support of safe and effective use of Mozarc Medical's products and therapies.
The Senior MS Specialist is considered a safety expert. With limited oversight, works on more difficult and complex Medical Safety activities, in collaboration with consulting expert physicians and other functions, including Quality, Regulatory, Risk Management, Complaint Handling, Research & Development, Clinical Affairs and Leadership.
Responsibilities

• Provides medical expertise and assessment to support patient safety throughout the product lifecycle.
• Collaborates with multiple functions including Research & Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, Training & Education and Clinical Affairs.
• Leverages medical knowledge and advocates for patient safety by providing Medical Safety input to internal functions and business processes across the product lifecycle.
• Completes applicable sections in Health Hazard Evaluations (HHE) and Field Corrective Action (FCA) documentation, monitors complaint rates, and assigns harms and hazards rating within documents (Preliminary Hazard Analysis (PHA), Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR)).
• Actively reviews scientific literature associated with assigned devices/therapies to support Post Market Surveillance activities.
• Participates in product complaint review meetings. Ensures that product complaints are correctly coded (IMDRF codes). Evaluates events and potential safety signals identified through Quality, Clinical, and Regulatory related Mozarc Medical's processes and recommends required action as needed.
• Authors high quality and accurate safety assessments per Mozarc Medical's processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
• Critically assesses and escalates newly identified safety issues per Mozarc Medical's processes for investigation assessment and action, which may include input on updates the product risk management file (RMF).
• Authors and reviews clinical study deliverables per Mozarc Medical's processes and completes assessments of pre- and post-market adverse events along with medical significance.
• Manages Medical Safety Committee and facilitates input from external medical and subject matter experts on safety matters.
• Provides 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).

Must Have:

• Bachelor's degree required with 7 years of clinical/medical experience within a kidney-related business or in a dialysis setting (i.e., hemodialysis unit, interventional cath lab) or an advanced degree with 5 years of clinical/medical experience within a kidney-related business or in a dialysis setting (i.e., hemodialysis unit, interventional cath lab).

Nice to Have

• Advanced degree, MD or RN.
• Medical/Patient Safety experience within the Medical device or pharma industry.
• Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience.
• Combination of Licensure and Medical Affairs/Safety or Clinical Management experience.
• Certified Professional In-Patient Safety, CPPS (within 1 year of hire).
• Experience in Risk Management and Risk Controls.
• Advanced understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
• Advanced understanding of kidney disease.
• Proficient ability to understand and apply practical medical and product knowledge in a competent and consistent manner for Medical Safety activities.
• Proficient ability to search and critically evaluate literature.
• Proven ability to effectively communicate verbally and in writing, and effectively influence diverse stakeholders (team members, functional partners, and healthcare professionals).
• Proven ability to make competent, risk-based, and timely Medical Safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness.

Why Work with Us?
Working here is highly rewarding - we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life.
It's essential our team members feel valued, supported and empowered too. That's why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work - helping you reach your potential and enjoy a career full of life-changing possibilities.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Other details

• Job Family Medical Safety
• Job Function Medical Affairs
• Pay Type Salary
• Employment Indicator Regular
• Min Hiring Rate $119,625.00
• Max Hiring Rate $199,375.00
• Travel Required Yes
• Travel % 25

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