Quality and Regulatory Director

Dermatologic Cosmetic Laboratories (DCL) is seeking a Quality and Regulatory Director to lead the quality and regulatory functions within the organization. The Quality and Regulatory Director will be responsible for ensuring that all DCL products meet the highest quality and safety standards while maintaining compliance with all regulatory requirements.

Responsibilities:

• Develop, implement and manage the Quality Management System (QMS) in accordance with relevant regulations, standards and company policies.

• Ensure compliance with FDA, EU, and other regulatory requirements, including overseeing the preparation of submissions, approvals, and registrations.

• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.

• Conduct audits of internal processes and external suppliers to ensure compliance with quality and regulatory requirements.

• Collaborate with cross-functional teams to ensure that all products are developed, manufactured, and tested in compliance with all applicable regulations, standards and company policies.

• Manage and develop the quality and regulatory team to ensure appropriate training and career development.

• Continuously review and improve the QMS to ensure its effectiveness and efficiency.

• Develop and maintain relationships with regulatory agencies, industry associations and other stakeholders.

Requirements:

• Bachelor’s degree in a scientific or technical field; advanced degree preferred.

• 10 years of experience in quality and regulatory affairs in the pharmaceutical, medical device, or cosmetic industry.

• Experience managing a team and developing talent.

• Demonstrated success in developing and implementing quality and regulatory strategies.

• In-depth knowledge of FDA and EU regulations.

• Strong analytical and problem-solving skills.

• Excellent verbal and written communication skills.

• Ability to work collaboratively with cross-functional teams.

• Strong leadership skills and the ability to influence and motivate others.

Dermatologic Cosmetic Laboratories offers a competitive compensation package and comprehensive benefits, including medical, dental, vision, and 401(k) plans. If you are passionate about quality and regulatory affairs and are looking for an opportunity to make a significant impact in a dynamic and growing company, please submit your resume for consideration.

You should be proficient in:

• Quality Inspection Experience
• Blueprint Reading
• Programming Machine Vision Systems
• Quality Control Data Analysis

Salary info:

$50 - $65 / hr