Senior Regulatory Affairs (RA) Specialist

Senior
Regulatory Affairs Specialist

Role
Summary

The Senior
Regulatory Affairs Specialist will support the development and execution of
global regulatory strategies for medical devices and combination products. This
role is responsible for preparing regulatory submissions, maintaining product
registrations, supporting product lifecycle activities, and ensuring compliance
with applicable global regulatory requirements. The position requires close
collaboration with cross -functional teams including R&D, Quality Assurance,
Clinical Affairs, Manufacturing, Supply Chain, and Marketing.

Key
Responsibilities

• Support the development and
  implementation of regulatory strategies for medical devices and
  combination products across global markets.
  
• Prepare, compile, review, and
  maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR
  Technical Documentation, and international registration dossiers.
  
• Perform regulatory impact
  assessments for product design changes, manufacturing changes, software
  updates, supplier changes, process changes, and labeling revisions.
  
• Support product lifecycle
  management activities by maintaining regulatory compliance and global
  market registrations.
  
• Prepare and maintain Technical
  Documentation, GSPR checklists, compliance matrices, and regulatory
  evidence packages.
  
• Review and update product
  labeling, Instructions for Use (IFUs), packaging artwork, UDI
  requirements, and marketing materials to ensure regulatory compliance.
  
• Support regulatory activities
  during product development, design reviews, risk management, verification
  and validation activities, and change control processes.
  
• Support regulatory strategy and
  documentation activities for combination products.
  
• Prepare documentation packages
  for internal audits, supplier audits, notified body audits, and regulatory
  inspections.
  
• Maintain regulatory databases,
  submission trackers, product registration records, and compliance
  documentation systems.
  
• Conduct regulatory research and
  support assessment of evolving regulatory requirements.
  

Qualifications
& Experience

• Bachelor’s or Master’s degree
  in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or
  related discipline.
  
• 5+ years of experience in
  Regulatory Affairs within the medical device or combination product
  industry.
  
• Experience preparing regulatory
  submissions and technical documentation for global markets.
  
• Working knowledge of FDA
  regulations, EU MDR requirements, and international medical device
  regulations.
  
• Experience with regulatory
  change assessments, product registrations, and lifecycle management
  activities.
  

Required
Skills

• Strong understanding of medical
  device regulatory requirements and submission processes.
  
• Knowledge of standards
  including ISO 13485, ISO 14971, IEC 60601 -1, ISO 20417, and ISO 15223 -1.
  
• Strong technical writing,
  documentation review, and analytical skills.
  
• Ability to manage multiple
  regulatory activities and meet timelines.
  
• Strong collaboration and
  communication skills with cross -functional teams.
  
• Attention to detail with strong
  compliance mindset.