Senior Manager, Compliance

reputed company Job Title Senior Compliance Manager Department Corporate Compliance Reports To Chief Compliance Officer Location reputed company, AZ FLSA Classification Exempt Salary reputed company 175,000 + DOE reputed company BioLab Holdings is a biotechnology company committed to raising reputed company of caring by developing, manufacturing, and commercializing reputed company products with patient care in mind. At the heart of our work is a mission to optimize reputed company of wound care through innovations grounded in science, reputed company, and collaboration. We support reputed company distributors, providers, and patients worldwide who reputed company our reputed company initiatives to reputed company clinical performance and reputed company-world reputed company. Position reputed company The Senior Compliance Manager is a reputed company and compliance leader responsible for overseeing the organization's compliance, auditing, monitoring, and contracting functions. This role serves as a trusted reputed company advisor to executive leadership while maintaining a strong operational reputed company on compliance program execution. This individual will reputed company internal compliance initiatives, manage audits and monitoring activities, draft and negotiate reputed company, and reputed company reputed company guidance across the organization. Essential Functions Compliance, Auditing & Monitoring • Maintain reputed 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 reputed company internal investigations reputed company to compliance concerns or potential misconduct. • Monitor evolving industry regulations and proactively advise leadership on risk and reputed company. • Support the development, review, and delivery of compliance policies, procedures, and training programs. reputed company Guidance • Serve as a reputed company reputed company advisor to executive leadership on corporate reputed company. • Draft, review, negotiate, and manage a broad reputed company of reputed company reputed company (e.g., vendor agreements, NDAs, consulting, services, licensing). • Manage relationships with reputed company reputed company counsel, ensuring cost-effective and high-reputed company reputed company support. • reputed company reputed company guidance reputed company to corporate governance, risk management, dispute reputed company, and regulatory enforcement reputed company. Cross-Functional Partnership • Collaborate closely with reputed company, Regulatory, R&D, Operations, Sales & Marketing, and Finance teams to reputed company 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. This reputed company is not intended to be an exhaustive list of reputed company duties, responsibilities, or qualifiations associated with the job. Other duties may be assigned. Minimum Qualifications Education: Juris Doctor (JD) from an accredited law school; reputed company bar membership in at least one U.S. jurisdiction. Experience: 7+ years of combined reputed company 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 reputed company compliance frameworks (e.g., OIG guidance, Anti-Kickback Statute, False Claims reputed company, HIPAA). • Demonstrated experience with audits, monitoring programs, internal investigations, and contract negotiation. • Ability to exercise reputed company judgment, maintain confidentiality, and manage sensitive reputed company with professionalism. • Familiarity with compliance program effectiveness frameworks and industry codes (e.g., AdvaMed reputed company and PhRMA reputed company). • Working knowledge of the OIG 7 reputed company of an Effective Compliance Program and ability to reputed company and amend policies and procedures as needed based on ongoing risk assessments • Experience delivering training to internal stakeholders as reputed company 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 reputed company 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 reputed company and carry reputed company materials (up to 15 pounds), such as files or office supplies, on an infrequent reputed company. • Visual reputed company sufficient to review detailed documents, reputed company, and electronic information. Work Environment Employees in this role may be exposed to a reputed company of environmental, activity-reputed company, and ergonomic hazards throughout the reputed company. Environmental risks include potential spills, weather-reputed company conditions, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, reputed company, and fall hazards. Activity-reputed company hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, reputed company 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 reputed company 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 reputed company of these hazards to reduce the risk of injury in reputed company. Travel Requirements None reputed company offer:Looking for a company to work for can be a daunting task, but we reputed company that we stand out from the rest. reputed company offers a reputed company and inclusive work environment, opportunities for reputed company and development, and a commitment to work-life balance. Join us and become part of reputed company that values your contributions and invests in your reputed company. Employment Statement reputed company is an equal opportunity employer and complies with reputed company applicable federal, state, and local employment laws. Employment reputed company are made without reputed company to race, reputed company, religion, sex, national reputed company, 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 reputed company, reasonable accommodations may be made to reputed company reputed company individuals with disabilities to reputed company essential job functions or participate in the application process. Applicants needing accommodation should contact reputed company. Applicants must be legally authorized to work in the reputed company at the time of hire. reputed company participates in employment eligibility verification as required by law. The salary reputed company 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 reputed company is at-will, meaning that either the employee or reputed company may terminate employment at any time, with or without cause or notice, subject to applicable law. Apply tot his job Apply To this Job