What You’ll Be Working On:
- Provide expertise in regulatory compliance across the medical / healthcare space, including 21 CFR Part 11, Annex 11, HIPAA, GDPR, GxP, and regional healthcare laws worldwide.
- Be conversant in the practical application of regulatory standards to all stages of the software product lifecycle, with an ability to communicate clearly with product and engineering teams.
- Be responsible for reviewing and approving validation of Reify products to ensure full compliance with regulatory requirements and company policies.
- Monitor and analyze regulatory developments and provide regular reporting to key stakeholders within the company.
- Support internal and external regulatory audits.
- Build and maintain collaborative relationships with internal and external stakeholders to accomplish key business objectives across departments.
- Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
What You Bring to Reify Health:
- 5+ years of experience working on, or closely with, product teams, preferably in the cloud software space.
- 3+ years of experience in software product compliance in the healthcare industry.
- Demonstrated experience in implementing and managing 21 CFR Part 11 compliance within the software industry. Leadership role / project management experience preferred.
- Practical experience interpreting regulatory standards. Law degree or other formal legal training preferred.
- Demonstrated experience with SaaS application and agile product development methodology
- Experience leading fast-moving cross-functional teams to drive compliance objectives.
- Highly detail-oriented with strong time management skills to manage multiple deadlines.
- Excellent communication skills, capable of communicating legal and regulatory standards clearly and pragmatically.
Compensation & Benefits
- Competitive Salary and Stock Options Salary and stock options commensurate to your experience and expertise
- Remote First Our workforce is geographically distributed so that we are attractive to a broader population of candidates
- Flexible Hours Plan your workday as you wish, just give us the majority of your core, creative hours that coincide with that of your team
- Comprehensive Health/Wellness Coverage 100% premium coverage for you (and >50% for your dependents) for: Top-tier health plan (with option of HSA), Dental, Vision, Disability (short-term and long-term), Life insurance (for your entire tenure at Reify), 24/7 access to doctor by phone or online via telemedicine coverage
- Retirement Plan 401(k) plan with employer matching program
- Company-provided Workstation You will be issued a brand new MacBook Pro laptop
- Location Convenience & Transportation For employees who are local to Boston, and want to visit the office, we are located two blocks from Downtown Crossing. Free monthly T pass. Full suite of office accommodations provided by WeWork: unlimited coffee, infused water, and more
- Vacation and Holiday Flexibility Generous paid time-off policy that accrues with your tenure at Reify which includes holiday flexibility and parental leave