Job Description

• The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices.
• This role involves ensuring compliance with global regulations, preparing and managing regulatory submissions, and acting as a liaison with regulatory agencies.
• Key Responsibilities: Develop and implement regulatory strategies for medical device products throughout their lifecycle. Prepare, review, and submit regulatory submissions, including 510(k), PMA, CE Mark, and other international submissions.
• Ensure compliance with applicable regulations, standards, and guidelines, including FDA, EMA, and other global health authorities.
• Monitor and interpret regulatory requirements and changes, providing proactive advice to internal teams
• Act as the primary point of contact with regulatory agencies, managing communications and negotiations to facilitate product approvals.
• Conduct risk assessments and provide recommendations to mitigate regulatory risks.
• Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory compliance.
• Provide training and support to company staff on regulatory compliance matters.

• Strong knowledge of regulatory requirements and submission processes for medical devices.
• Experience with regulatory submissions and interactions with health authorities.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in regulatory software and tools.

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