Regulatory Officer

Key Responsibilities:

  Ensure that medical devices and instruments comply with local and international regulatory standards.

  Prepare and submit regulatory submissions, including product registrations, certifications, and technical files.

  Work with product development teams to ensure devices meet regulatory requirements and get necessary approvals.

  Stay up-to-date with changes in regulations, guidelines, and industry best practices to ensure ongoing compliance.

  Support regulatory audits and inspections by maintaining proper documentation and responding to regulatory bodies.

Required Skills:

  Knowledge of medical device regulations.

  Excellent attention to detail and organizational skills.

  Ability to interpret and apply complex regulatory requirements.

  Strong communication skills.

  Experience with regulatory submissions and documentation.

Qualifications:

  Previous experience in regulatory affairs within the medical device industry is preferred.