Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for ensuring compliance with applicable regulatory requirements, including 21 CFR Part 820 GMP, ISO 13485:2016, and other international standards. This role will support product development, registration, and post-market activities to ensure Polysciences, Inc. & Kyfora Bio LLC products meet all regulatory, safety, compliance and quality requirements.

Essential Functions:

Provide regulatory guidance during new product design and development to ensure compliance with applicable standards and regulations.

• Prepare, review, and submit regulatory documentation for Drug Master Files, product approvals, registrations, and renewals (e.g., FDA submissions).
• Maintain compliance with 21 CFR Part 820 GMP, ISO 13485:2016, and other relevant quality system requirements.
• Support external audits, including supplier audits, customer audits, FDA inspections and Notified Body audits.
• Conducts Internal Audits and maintains the Internal Audit system.
• Ensure product labeling, packaging, and promotional materials meet regulatory requirements.
• Monitor and assess regulatory changes, guiding cross-functional teams on potential impacts.
• Collaborate with R&D, Quality, Sales, Marketing, and Manufacturing and other applicable departments to ensure regulatory compliance throughout the product lifecycle.
• Participate in risk management activities, including design controls, change control, and NC/CAPA processes.
• Maintain regulatory records, databases, and documentation to support audits and inspections.
• Conduct regulatory gap assessments on products and implement necessary actions to address the identified gaps.
• Quality Agreement review and interpretation for QA Management approval.

Qualifications

Education Required: Bachelor's Degree                                                                                

Certification(S):

Auditor Training Required.

Lead Auditor Certification preferred.

Regulatory Affairs Certification (RAC) or Regulatory Compliance Certification (RCC) preferred.

Computer Skills Required:

Proficiency with document management software and Microsoft Office Suite.

Preferred experience with Enterprise Resource Planning (ERP) systems for tracking suppliers, materials, and customer complaints.

Preferred experience with electronic QMS systems for tracking and reviewing documents, training, quality issues, CAPA, effectiveness checks, and change controls.

Other Qualifications:

• 3+ years of regulatory affairs experience in a medical device or pharmaceutical manufacturing environment.
• In-depth knowledge of 21 CFR Part 820 and ISO 13485:2016.
• Knowledge of 21 CFR Part 210,211 requirements preferred.
• Strong understanding of design controls, risk management, and product lifecycle requirements.
• Excellent organizational, communication, and technical writing skills.
• Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.
• Familiarity with REACH, EU MDR, MDSAP, and international regulatory pathways is a plus.
• Experience with Good Manufacturing Practices (GMP)
• Strong analytical and problem-solving abilities.
• Highly organized and detail-oriented, with the ability to manage multiple tasks, systems and projects simultaneously.
• Experience with SAP preferred.
• Strong written and verbal communication skills to interact effectively with various departments, such as Quality, Operations, and Engineering.
• Experience with audit preparedness and support during internal and external audits.