Regulatory Affairs Specialist

Description

• Provide tech file support.
• Assist in the preparation of dossiers and pre-submission and submission packages for regulatory agencies.
• Support End of Product Lifecycle (obsoletion) project.
• Collect and organize information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations.
• Compile and organize materials for pre-submission reports and communications.
• Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings.
• Support RA dashboard and system integration for RA systems.
• Monitor the regulatory environment, including specific regulations, guidance, and relevant information by product types and geography.
• Research local, national, and international requirements, applicable guidance and standards, and options for regulatory submissions, approval pathways, and compliance activities.
• Support assessment training and any mitigation work as part of QMS revamp work.
• Help resolve open CAPA/NC (e.g., Training, etc.).
• Support eIFU project and Ad/Promo migration aligned with procedures.
• Review design changes.
• Assist in mapping legacy procedures to identify gaps, overlaps, and alignment opportunities for integration and audit readiness.
• Offset workload from RA DPO to conduct Gap assessment and conduct any resolution implementation as a result of the Gap assessment in RA QMS.
• Identify information sources and resources for local, regional, and global regulations.
• Determine and communicate submission and approval requirements.
• Assist in the development of regulatory procedures and SOPs.
• Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information.
• Support migrating documents into systems like Propel and SharePoint, ensuring correct formatting, metadata accuracy, and linkage to training records where applicable.
• Organize materials from preclinical and clinical studies for review and assist in the review process.
• Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Provide information used to evaluate proposed products for regulatory classification and jurisdiction.
• Track the status of applications under regulatory review and provide updates to the regulatory team.
• Support regulatory submissions for medical devices.

Requirements

• General FDA and EU MDR knowledge.
• 3 - 5 years of experience in an equivalent position within an R&D environment.
• RAC Certification (preferred).
• Bachelor's or Master’s degree in Regulatory Affairs, Engineering, or equivalent discipline.
• Experience with post-market and change management.
• QMS awareness/knowledge.

Benefits

• Health Spending Account (HSA)
• Employee Assistance Program
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Short and long-term disability
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

Training + Development

Interview process

Visa Sponsorship

Security clearance