Qualifications

• Knowledge of quality and regulatory requirements for medical devices and pharmaceuticals.
• Strategic planning skills for maintaining compliant quality and regulatory systems.
• Experience leading and managing complex projects.
• Strong decision-making capabilities.
• Proficient analysis and problem-solving skills.
• Exceptional organizational abilities and attention to detail.
• Demonstrated success in negotiations with regulatory and notified bodies.
• Excellent communication skills, both written and verbal.
• Ability to interpret complex technical documents and medical terminology.
• Strong proficiency in Microsoft Office applications.
• Ability to juggle multiple tasks and possess high energy for day-to-day activities.

Responsibilities

• Engage with business leaders to uphold compliance standards and support market growth.
• Mitigate compliance risks through quality and compliance plans in response to audits and regulatory changes.
• Communicate compliance strategies effectively with HS/Business Leadership.
• Educate QA/RA teams on regulatory requirements.
• Oversee and direct internal and supplier audit scheduling and execution for quality assurance.
• Monitor and ensure timely completion of corrective and preventive actions (CAPA).
• Manage regulatory inspections and respond to findings accordingly.
• Ensure safe handling and storage practices for medical devices, pharmaceuticals, and food products.
• Plan and administer state licensing applications and renewals.
• Develop and evaluate staff for efficient operation and provide necessary coaching and training.
• Engage in regular management meetings to discuss regulatory and compliance topics and participate in special projects.

Benefits

• Comprehensive benefits package including health, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Opportunities for professional development and training.
• Paid time off and holiday pay.
• Flexible work environment promoting work-life balance.