Remote Operational Risk Manager Jobs in Bethlehem, PA

As a Medical Safety Specialist II (MSSII) you will have an integral role in the day-to-day functioning of the global medical safety organization. In this vital role, you will execute upon medical safety processes globally at Olympus. As an individual contributor you will influence the science and practice of all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge to collaborate and influence patient safety in activities being performed cross-functionally across the product lifecycle for all Olympus therapeutic areas.

You will report directly to the Medical Safety Director as a member of the global medical safety team. You must be adept at cultivating strong collaborative relationships across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance.  

• Complaint Assessment:  Uses tools created for consistency and SOPs to medically assess causality and severity of adverse events reported to Olympus.  Provides recommendations for escalation.
• Risk Management:  Develops expertise of the risk management file documents for assigned products with responsibility to provide information related to observed and potential patient harm, severity, and mitigations to reduce potential for harm.
• QARA Processes:  Develops an understanding of medical safety's role in QARA processes across the product life cycle and provides Medical Safety review and approval for PMS documentation, labeling/IFU creation, Clinical Evaluation Reports, developing responses to inquiries from regulators, Human Factors Engineering reports, non-conformance dispositions, and CAPA.
• Cross-functional meetings:  Uses Medical subject matter expertise to represent Medical Safety in cross-functional meetings related to HHA, FCA, trending, and complaint review boards; internally aligns on and contributes to escalation of key events or issues with potential for safety impact.  Engages more experience team members if additional data or information is needed to facilitate medically sound decisions related to patient safety.
• Medical Safety or cross-functional projects:  Plays an active role in contributing to Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. 
• Uses clinical knowledge and experience to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies.
• Searches, reviews, trends, understands, and interprets adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
• Demonstrates knowledge and experience working with:

• • Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820)
  • Various standards (GCP, ISO 13485, ISO 14971)
  • Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs)
  • Corrective Actions - Preventative Actions (CAPAs)
  • Health Hazard Assessment & Field Corrective Actions
  • Resolving product non-conformances
  • IMDRF dictionary terms and proficiency in adverse event coding and reporting
  • Post market surveillance, escalations, and mandatory safety reporting requirements
  • Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and Control

• Maintains knowledge of Olympus standard operating procedures, guidance, work instructions, training, and competencies.
• Demonstrates strong self-motivation and individual leadership skills, including the ability to communicate and influence multi-departmental, cross functional teams and contribute to the resolution of quality-related issues in a timely and effective manner.
• Demonstrates experience staying engaged with worldwide clinical practice guidelines, safety requirements, and global Competent Authority regulations. 

Required:

• BS/BA Degreed Health Care Professional required.
• Minimum of 4 years of experience working as a Health Care Professional (RN). DNP, PA-C preferred.  Direct patient care experience is required (Hospital, Medical or Clinical Practice, with a preference for clinical experience in the areas of Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control).
• Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience (Medical Device preferred to Pharma) OR Progressive leadership experience in the health care setting. Medical Safety (Medical Device preferred to Pharma) or Risk Management (Medical Device) experience.
• Extended periods of time doing computer-based work.
• Extended hours to accommodate international / intercontinental global time schedules.
• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact in-person and virtually with peers and co-workers.
• Travel up to 10% may be required.