Senior Manager, Compliance
BioLab Holdings, Inc.
Description Job Title Senior Compliance Manager Department Corporate Compliance Reports To Chief Compliance Officer Location Mesa, AZ FLSA Classification Exempt Salary Range 175,000 + DOE Company Summary BioLab Holdings is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact. Position Summary The Senior Compliance Manager is a legal and compliance leader responsible for overseeing the organization's compliance, auditing, monitoring, and contracting functions. This role serves as a trusted legal advisor to executive leadership while maintaining a strong operational focus on compliance program execution. This individual will lead internal compliance initiatives, manage audits and monitoring activities, draft and negotiate contracts, and provide legal guidance across the organization. Essential Functions Compliance, Auditing & Monitoring
qualifiations associated with the job. Other duties may be assigned. Minimum Qualifications Education: Juris Doctor (JD) from an accredited law school; active bar membership in at least one U.S. jurisdiction. Experience: 7+ years of combined legal and compliance experience in the pharmaceuticals, medical device, or life sciences industries Certifications: None required Knowledge, Skills, and Abilities • Strong working knowledge of FDA regulations and healthcare compliance frameworks (e.g., OIG guidance, Anti-Kickback Statute, False Claims Act, HIPAA).
• Demonstrated experience with audits, monitoring programs, internal investigations, and contract negotiation.
• Ability to exercise sound judgment, maintain confidentiality, and manage sensitive matters with professionalism. • Familiarity with compliance program effectiveness frameworks and industry codes (e.g., AdvaMed Code and PhRMA Code). • Working knowledge of the OIG 7 Elements of an Effective Compliance Program and ability to develop and amend policies and procedures as needed based on ongoing risk assessments • Experience delivering training to internal stakeholders as well as distributors. Experience creating role-based training
Physical Requirements • Prolonged periods of sitting and working at a computer.
• Frequent use of hands and fingers for typing, document review, and operating standard office equipment.
• Ability to communicate effectively, including participating in meetings, presentations, and discussions.
• Occasional standing, walking, bending, and reaching in an office environment.
• Ability to lift and carry light materials (up to 15 pounds), such as files or office supplies, on an infrequent basis.
• Visual acuity sufficient to review detailed documents, contracts, and electronic information. Work Environment Employees in this role may be exposed to a variety of environmental, activity-related, and ergonomic hazards throughout the workday. Environmental risks include potential spills, weather-related conditions, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, and fall hazards. Activity-related hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards are also present,
including lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing.
Specific job tasks such as sitting at a workstation for extended periods can lead to back, shoulder, hand, arm injuries, and eye strain, while prolonged standing may result in strains, sprains, and leg or knee injuries. Walking throughout the building introduces the risk of slips, trips, falls, and strains, particularly if walkways are obstructed or wet. Additionally, cleaning up spills can pose hazards such as slips, trips, strains, and potential exposure to bloodborne pathogens. Overall, employees must remain aware of these hazards to reduce the risk of injury in the workplace. Travel Requirements None What we offer: Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success. Employment Statement The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law. In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources. Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law. The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable. Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.
- Maintain the company's corporate compliance program in alignment with FDA, OIG, and other applicable regulatory requirements.
- Design and execute risk-based compliance monitoring and internal audit activities; identify gaps and implement corrective actions.
- Conduct and oversee internal investigations related to compliance concerns or potential misconduct.
- Monitor evolving industry regulations and proactively advise leadership on risk and impact.
- Support the development, review, and delivery of compliance policies, procedures, and training programs.
- Serve as a primary legal advisor to executive leadership on corporate matters.
- Draft, review, negotiate, and manage a broad range of commercial contracts (e.g., vendor agreements, NDAs, consulting, services, licensing).
- Manage relationships with external legal counsel, ensuring cost-effective and high-quality legal support.
- Provide legal guidance related to corporate governance, risk management, dispute resolution, and regulatory enforcement matters.
- Collaborate closely with Quality, Regulatory, R&D, Operations, Sales & Marketing, and Finance teams to embed compliance into day-to-day business activities.
- Advise leadership on compliance implications of new products, partnerships, and strategic initiatives.
- Promote a culture of ethics, accountability, and transparency across the organization.
qualifiations associated with the job. Other duties may be assigned. Minimum Qualifications Education: Juris Doctor (JD) from an accredited law school; active bar membership in at least one U.S. jurisdiction. Experience: 7+ years of combined legal and compliance experience in the pharmaceuticals, medical device, or life sciences industries Certifications: None required Knowledge, Skills, and Abilities • Strong working knowledge of FDA regulations and healthcare compliance frameworks (e.g., OIG guidance, Anti-Kickback Statute, False Claims Act, HIPAA).
• Demonstrated experience with audits, monitoring programs, internal investigations, and contract negotiation.
• Ability to exercise sound judgment, maintain confidentiality, and manage sensitive matters with professionalism. • Familiarity with compliance program effectiveness frameworks and industry codes (e.g., AdvaMed Code and PhRMA Code). • Working knowledge of the OIG 7 Elements of an Effective Compliance Program and ability to develop and amend policies and procedures as needed based on ongoing risk assessments • Experience delivering training to internal stakeholders as well as distributors. Experience creating role-based training
Physical Requirements • Prolonged periods of sitting and working at a computer.
• Frequent use of hands and fingers for typing, document review, and operating standard office equipment.
• Ability to communicate effectively, including participating in meetings, presentations, and discussions.
• Occasional standing, walking, bending, and reaching in an office environment.
• Ability to lift and carry light materials (up to 15 pounds), such as files or office supplies, on an infrequent basis.
• Visual acuity sufficient to review detailed documents, contracts, and electronic information. Work Environment Employees in this role may be exposed to a variety of environmental, activity-related, and ergonomic hazards throughout the workday. Environmental risks include potential spills, weather-related conditions, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, and fall hazards. Activity-related hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards are also present,
including lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing.
Specific job tasks such as sitting at a workstation for extended periods can lead to back, shoulder, hand, arm injuries, and eye strain, while prolonged standing may result in strains, sprains, and leg or knee injuries. Walking throughout the building introduces the risk of slips, trips, falls, and strains, particularly if walkways are obstructed or wet. Additionally, cleaning up spills can pose hazards such as slips, trips, strains, and potential exposure to bloodborne pathogens. Overall, employees must remain aware of these hazards to reduce the risk of injury in the workplace. Travel Requirements None What we offer: Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success. Employment Statement The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law. In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources. Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law. The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable. Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.
Vacancy posted 4 days ago
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