Product Surveillance Regulatory Affair Leader

Job Description Summary

Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE HealthCare In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Job Description

• Uses skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
• A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
• Bachelor’s Degree & minimum of 3 years experience in the medical device or pharmaceutical industry or
• Demonstrated experience operating in a highly regulated environment; proven application of analytic skills in a regulatory environment
• Knowledge of the FDA’s Quality System Regulations; experience working within a Quality Management System
• Ability to prioritize, plan & evaluate deliverables to established strategic goals
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
• Strong problem solving, influencing and negotiation skills
• Ability to work well independently & in a team setting
• Prior experience using spreadsheet and presentation software
• Strong working knowledge of Medical Device regulations, such as FDA CFR 21 Parts 820, 803, 806 & 1002/03; ISO 13485; MDD; CMDR; EU MDR
• Regulatory Affairs Certification (RAPS)
• Experience with ISO 14971 (Risk Management)
• Experience with IEC 60601, 2nd Edition (if involved with electro-mechanical equipment)
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
• Experience with working across cultures/countries/sites
• Demonstrated ability to identify, influence and lead process improvements and procedural changes
• Proven experience in Nuclear Medicine medical devices.