Overview

Reify Health is changing the way medicines are developed by connecting and empowering the clinical trial ecosystem. We are a team of researchers, entrepreneurs, technologists, and healthcare-obsessed professionals building solutions that eliminate some of the biggest challenges in clinical research.
We care about the people who care for people…and we have fun while doing it.
By joining our team, you will serve as a key liaison between the Compliance team and Reify’s Product and Engineering teams. This person will play a crucial role in designing and implementing Reify’s compliance strategy across all existing and future products.
The Product Compliance Manager will work closely with teams across Reify’s product and engineering functions to advise on all matters related to regulatory compliance, with a strong emphasis on digital data management in the global healthcare space. This person will be regularly involved in higher-level strategic conversations and will also engage with various team members on a granular level to manage compliance risk and provide practical guidance at all stages of the product lifecycle. A successful candidate will have hands-on experience implementing 21 CFR Part 11 compliance efforts at a fast-paced technology company.

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
We value diversity and believe the unique contributions each of us brings drives our success. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Note: We are unable to sponsor work visas at this time.