Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 crossfunctional 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 problemsolving abilities.
- Ability to work independently and manage multiple projects simultaneously.
- Proficiency in regulatory software and tools.
Employment Type
Full Time
