Regulatory Affairs Manager

Responsibilities:

Regulatory Strategy: Develop and implement comprehensive regulatory strategies for medical aesthetic products, including devices, drugs, and biologics.

Regulatory Submissions: Prepare and submit regulatory filings, such as 510(k)s, IDEs, INDs, and NDAs, to regulatory agencies like the FDA.

Regulatory Compliance: Ensure compliance with all applicable regulatory requirements, including FDA, EU MDR, and other international regulations.

Clinical Trials: Oversee and manage clinical trials, including protocol development, IRB submissions, and data analysis.

Post-Market Surveillance: Monitor product performance post-market, including adverse event reporting and product recalls.

Labeling and Packaging: Review and approve product labeling and packaging to ensure compliance with regulatory requirements.

Regulatory Intelligence: Stay updated on regulatory changes and industry trends to proactively identify potential risks and opportunities.

Regulatory Audits: Prepare for and conduct regulatory audits, including FDA inspections.

Cross-Functional Collaboration: Work closely with R&D, clinical affairs, quality assurance, and marketing teams to ensure regulatory compliance throughout the product lifecycle.

• Marketing-compliance: Collaborate with sales & marketing teams to ensure compliance with local and international regulatory requirements.
• Prepare and review regulatory submissions, such as clinical trial protocols and product labeling.
• Stay updated on regulatory changes and their impact on product development and commercialization.

iii) Qualifications

• Advanced degree in medicine (MD or DO) or equivalent.
• Board certification in dermatology, plastic surgery, or a related field.
• Extensive experience in aesthetic medicine, including a deep understanding of injectables, lasers, and other cosmetics.
• Strong clinical research and publication record.
• Excellent communication and presentation skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong understanding of regulatory requirements and clinical trial methodologies.
• Ability to travel domestically and internationally as needed.
• Proven leadership and interpersonal skills.