The Senior Director of Privacy and Compliance will be responsible for overseeing and managing a comprehensive compliance and business integrity program for RefleXion. This position, reporting to the Head of Legal, will update, strengthen, and maintain all Company compliance processes and procedures that are part of the overall Compliance Program. The Compliance program focuses on all regulations and privacy, with a strong focus on the regulations related to operating within the healthcare industry. The Senior Director of Compliance and Privacy will have significant interaction with employees at all levels of the Company, including executive leadership. Candidate may choose to work fully or partially remote for this role upon final agreement with the hiring manager.
- Manage and maintain RefleXion’s Code of Conduct (drafted in accordance with the AdvaMed Code of Ethics)
- Implement policies around compliance with the Sunshine Act
- Develop and maintain a privacy infrastructure to allow for compliance with HIPAA and all relevant regulations (e.g. CCPA and GDPR)
- Maintain a current working knowledge of Federal and State regulations and policies as they affect the Company through routine review of manuals, Federal Register notices, applicable government and/or industry related internet information sites
- Interface and provide assistance to the RefleXion Quality Assurance and Regulatory Teams on matters involving applicable CFR, ISO and IEC regulations and standards.
- Work with other members of the Legal department on compliance and governance issues
- Ensure identified compliance risks are mitigated/remediated through creation and revision of applicable policies
- Measure compliance by conducting routine and/or focused internal audits of policy/procedures adherence as well as coordinating autids generated by external sources
- Develop and oversee annual compliance/business ethics training for all employees, vendors, and affiliates as required
- Advise and make recommendations to executive leadership and the Board of Directors about regulatory compliance issues on a regular basis as required
- Develop, maintain and effectively communicate any and all additional compliance policies as needed
- Other duties as assigned
- Bachelor’s Degree in healthcare, business, or organizational related field required; Graduate Degree in hospital or business administration, or related field or J.D. preferred (e.g. MHA, MPA, MBA) is highly preferred.
- Minimum of at least twelve (12) years of experience in regulatory compliance and/or government regulatory affairs roles, as well as experience in a life sciences/startup environment, with relevant global, federal and state compliance and operational compliance experience. Familiarity with ISO 13485 and FDA 21 CFR Part 820 a plus.
- Significant familiarity with Sunshine Act Compliance
- Significant familiarity with HIPAA privacy and security regulations and GDPR as applied to life sciences and clinical research data collected at clinical sites globally. CIPP/US (Certified Information Privacy Professional/Unites States) certification is highly desirable
- Highly developed analytical, communication, critical-thinking and problem-solving skills.
- Ability to interpret legislation and regulations, implement policies and procedures effectively
- Interpersonal skills including the ability to listen actively and responsively, delegate responsibilities appropriately and facilitate effective and successful relationships within a matrix management structure
- Strong team player with strong collaboration and project/portfolio management skills. Ability to work seamlessly with other members of extremely collegial and supportive business team and organization
- Knowledge of how legislative and regulatory processes work, ability to research laws, regulations as needed.
- Ability and willingness to occasionally travel nationally and internationally as required by the role.
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
- Competitive compensation and stock option package
- Three (3) weeks PTO to start
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
- Free daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site