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.

& 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.