Regulatory Affairs

Overview:

Key Responsibilities:

• Developing and implementing regulatory strategies for product approval and market compliance
• Ensuring all regulatory submissions and documentation are accurate and in compliance with relevant regulations
• Collaborating with crossfunctional teams to provide regulatory guidance and support
• Reviewing and approving product labeling advertising and promotional materials for compliance
• Conducting regulatory research to stay updated on changes in regulations and guidelines
• Preparing and submitting regulatory filings including 510(k)s PMAs and other regulatory submissions
• Participating in regulatory agency interactions and audits
• Assessing and communicating potential impact of regulatory changes on the business
• Managing regulatory documentation and records
• Participating in the development and review of SOPs work instructions and quality system regulations

Required Qualifications:

• Bachelors degree in a scientific or technical field such as biology chemistry or pharmacy
• 3 years of experience in a regulatory affairs role in the healthcare or pharmaceutical industry
• Knowledge of FDA regulations and other regulatory requirements
• Experience with regulatory submissions and approvals such as 510(k)s PMAs or IDEs
• Strong understanding of quality management systems and regulatory compliance
• Excellent analytical and problemsolving skills
• Effective written and verbal communication skills
• Detailoriented with strong organizational abilities
• Ability to collaborate and work effectively in crossfunctional teams
• Experience interfacing with regulatory agencies and notified bodies

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