Regulatory Affairs and Compliance Associate

Regulatory Affairs and Compliance Associate

Location:
Irvine, CA

Company:
ELIXIR MD Inc.

Industry:
Medical Devices (Global Aesthetic & Surgical Markets)

About Us

ELIXIR MD Inc. is a fast-growing fully integrated medical device innovator, headquartered in Irvine, CA. and proud Made in the USA ethos. Our manufacturing, supply, sales and support operations are global with sales in 22 countries (and growing). Our flagship device is transforming the way plastic surgeons practice worldwide. With rapid adoption, global expansion, and highly specialized logistics for a growing portfolio of Devices, we are looking for a Full time Regulatory Affairs and Compliance Associate to help scale our business with precision, creativity, and discipline.

Position Summary

The Regulatory Affairs and Compliance Manager is responsible for ensuring that
Elixir MD Inc.
operates in full compliance with all applicable federal, state, and local regulations governing medical, healthcare, and corporate operations. This role oversees regulatory strategy, compliance monitoring, licensing, audits, and internal controls helping the company maintain operational integrity and regulatory excellence as it scales.

The ideal candidate has a deep understanding of medical and healthcare regulations, FDA, FTC, HIPAA, OSHA, and state medical board compliance, with a proactive approach to risk mitigation and continuous improvement.

Key Responsibilities

• Develop, implement, and maintain company-wide regulatory compliance programs in accordance with FDA, FTC, and state health authority requirements.
• Prepare and manage regulatory submissions, renewals, and registrations for company products and services (as applicable).
• Stay current with evolving medical, pharmaceutical, and aesthetics industry regulations and communicate updates to leadership.
• Liaise with federal and state regulatory agencies, auditors, and external partners when necessary.
• Establish and maintain policies, procedures, and systems that ensure compliance with HIPAA, OSHA, state medical board, and corporate regulations.
• Conduct regular internal compliance audits and risk assessments; develop corrective action plans as needed.
• Monitor company practices related to marketing claims, clinical operations, and professional conduct to ensure compliance with applicable laws and ethical standards.
• Review contracts, marketing materials, and operational documents for regulatory accuracy and risk exposure.
• Partner with operations and product teams to ensure quality management systems (QMS) align with regulatory expectations.
• Support documentation and recordkeeping practices to ensure traceability, accountability, and readiness for inspection.
• Oversee incident reporting, CAPA (Corrective and Preventive Actions), and internal investigations.
• Develop and deliver compliance training programs to employees, management, and contractors.
• Serve as a resource for staff regarding compliance questions, reporting obligations, and best practices.
• Promote a company culture centered on ethical conduct, integrity, and accountability.
• Lead internal and external audits and coordinate responses to regulatory inspections.
• Identify compliance risks and gaps; design and implement strategies to minimize exposure.
• Maintain documentation for all regulatory and compliance-related activities to ensure transparency and traceability.

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Healthcare Administration, or related field (Master's preferred).
• 5–8 years of experience in regulatory affairs or compliance within the medical, healthcare, or life sciences industry.
• Strong understanding of FDA, HIPAA, OSHA, FTC, and state medical board regulations.
• Experience preparing and managing regulatory submissions, audits, and compliance reports.
• Proven ability to interpret complex regulations and translate them into actionable internal policies.
• Excellent written, verbal, and interpersonal communication skills.
• High attention to detail, analytical mindset, and professional integrity.
• Certifications such as RAC (Regulatory Affairs Certification) or CHC (Certified in Healthcare Compliance) preferred.