Senior Manager Product Compliance

Senior Manager Product Compliance

Requirements

• 10+ years of experience in a Quality role in the medical device industry is required.
• 4+ years’ experience as a people lead/manager
• Bachelor’s Degree in an engineering, scientific or other relevant field is required.
• Demonstrated ability to understand complex technical issues and direct experience working with surgical medical devices/instrumentation (US: Class II and III) in (any) area of Capital Equipment, Software, Wireless technology, Disposable/Reusable instrumentation and/or implantable devices
• Demonstrated experience/exposure to aspects of Medical Device Design Control and/or Production/Process Controls, and/or Corrective/Preventive Actions and/or Corrections/Removals
• Demonstrated ability to work in highly cross-functional teams, including direct experience working with engineering, clinical and risk management functions.
• Demonstrated ability to effectively manage teams/direct reports, provide guidance, make decisions, and manage growth
• Applied understanding of US FDA Quality System Regulations, ISO 13485, ISO 14971
• Ability to be a team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use risk based judgment.
• Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment.

Responsibilities

• Compliance representative on escalation meetings, to understand the product/process issue, risk, clinical impact and help establish escalation decisions/conclusions.
• Support Product Investigations, help with determination of field impact, and any associated field actions, corrections and/or removals.
• Oversee field action strategy, execution and implementation based on understanding of product technical issue, clinical/product/user risk, and actions to be taken with the product in the field.
• Help author and review field action and customer letters/communication to ensure the documentation aligns with the overall strategy and meets the regulatory/compliance requirements.
• Help author and review any follow-up questions, responses related to the field actions.
• Help provide guidance on a variety of ad-hoc product/compliance questions, including helping research the regulations, current process/practices within ISI, industry/regulatory agency expectations etc.
• Provide guidance, review and approve various documents on behalf of Reg. Compliance, ranging from EDFs, PIRs, customer facing materials, technical bulletins, QS procedures.
• Participate in process improvements, streamlining and scalability associated with above processes.
• Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies.
• Support the Quality System and Compliance (QSC) team overall, as needed, related to QRB/Management Review, Audits, Facility Changes, CAPAs, Process improvements etc.

Preferred Qualifications

• Master’s Degree in engineering or scientific field preferred.