Assistant General Counsel, Regulatory Compliance

Seeking an Assistant General Counsel, Regulatory Compliance to provide strategic legal guidance on FDA-regulated medical device products. Key responsibilities include supporting regulatory compliance and leading compliance initiatives. Ideal for candidates with extensive experience in FDA medical device regulations and strong analytical and communication skills.

Skills

• fda medical device regulations
• gmp/gdp investigations
• regulatory risk mitigation
• product development
• quality system regulation
• product promotion compliance
• enrollment in new technologies (ivd, ruo)
• promotional materials compliance
• product labeling
• analytical skills
• field actions
• regulatory affairs
• quality assurance
• regulatory compliance
• stakeholder management