Regulatory Affairs Specialist
We have a current opportunity for a Regulatory Affairs Specialist on a contract basis.
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.
- Maintain regulatory documentation and records in accordance with company policies and procedures.
Qualifications:
- Bachelor's degree in life sciences, health sciences, pharmacy, or a related field; advanced degree preferred.
- 3-5 years of experience in regulatory affairs within the medical device industry.
- Strong knowledge of regulatory requirements and submission processes for medical devices.
- Experience with regulatory submissions and interactions with health authorities.
- Regulatory Affairs Certification (RAC) or equivalent certification preferred.
- 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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