Abbott's Heart Failure Division needs to maintain overall Quality Management System compliance to internal policies, applicable standards, and external regulatory requirements.
Requirements
- Knowledge of regulations and standards Such as MDD, MDSAP, MDR, NMPA and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO 13485 and 14971.
- Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other similarly regulated environment.
- Prior experience in interfacing with Regulatory and Notified Bodies
- Hands on experience with CAPAs
- Experience with Supplier Quality
- Understands applicability of Quality System Regulations
- Detail-oriented with a strong focus on regulatory compliance.
Responsibilities
- The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to ensure that all sites within the business are compliant and audit ready at all times.
- Acts as a key influential leader, responsible for driving cross-site audit support and audit readiness initiatives to improve quality systems, and overall organizational compliance to internal/external requirements.
- Ensures cross-functional partners and peers understand quality system requirements and how they impact product quality and regulatory compliance.
- Represents the division within Abbott through Corporate based community of practice as well as external Regulatory Intelligence Forums.
- Utilizes experience and knowledge gained from audits, internal assessments, and cross-business community of practice to proactively address potential compliance gaps.
- Responsible for oversight and administration of division’s CAPA system and driving effective resolutions to identified issues.
- Responsible for tracking timeliness of change assessments for external requirements and associated metrics.
Other
- Bachelors Degree in related field
- Five (5) years in a management capacity.
- Excellent communication, leadership, and analytical skills
- Ability to work independently and as part of a team.
- Strong problem-solving and decision-making abilities.
