The Regulatory Specialist – Field Actions supports enterprise wide Regulatory Transformation and Operations initiatives, with a primary focus on Field Actions, providing operational, analytical, and documentation support across transformation programs that impact postmarket regulatory activities.
$71,300.00 - $97,750.00 USD Salary
- Support enterprise regulatory transformation team initiatives with a primary focus on Field Actions, including recalls, corrections and removals, FSN/FSCA activities, and other postmarket regulatory obligations
- Support the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country‑specific timelines, and ensuring required documentation is complete, accurate, and inspection‑ready
- Assist with preparation, maintenance, and coordination of field action documentation, including HHE coordination, regulatory submissions, health authority communications, internal trackers, and supporting records
- Support policy and advocacy activities, including preparation of policy summaries, tracking regulatory consultations and coordination of industry working group participation as they pertain to field actions
- Assist in documenting, maintaining, and harmonizing regulatory processes, SOPs, templates, and process maps in support of field action compliance and other regulatory compliance activities
- Bachelors degree in Science, Engineering, Regulatory Affairs, or other technically related field
- Masters degree in Science, Engineering, Regulatory Affairs, or other technically related field
- Doctorate/PhD degree in Science, Engineering, Regulatory Affairs, or other technically related field
- Nice to have: Regulatory Affairs Certification (RAC)
- Nice to have: Experience supporting regulatory correspondence with Health Authorities and Notified Bodies related to postmarket actions
- medical insurance
- dental insurance
- vision insurance
- life insurance
- short-term disability