About
Prelude is a life science technology company looking to make the world safer and healthier by accelerating new product development of life-saving medicine and devices for humans and animals. Our mission is to simplify clinical research through smarter technology and superior service. Clinical trial designs are becoming increasingly complex, making new research more daunting and labor-intensive for clinical research organizations of all sizes. With Prelude’s Clinical Data Management (CDMS) platform, complex research is made easy through the industry’s most user-friendly, flexible eClinical technology platform, enabling easy, adaptable trials and automating 90%+ of clinical data management work.
Description
The Compliance Associate supports the Director of Compliance in maintaining and enhancing the company’s quality and compliance functions. This role involves ensuring adherence to regulatory standards, participating in quality management system (QMS) activities as per ISO 9001, and assisting in compliance with industry regulations such as 21 CFR Part 11, GDPR, HIPAA, EudraLex Annex 11, and GCP (Human and Animal). The Compliance Associate will collaborate with various teams across the organization to ensure that compliance processes are documented and implemented effectively.
Responsibilities
- Assist in maintaining and updating the internal Quality Management System (QMS) and ensure it aligns with ISO 9001 and other applicable regulatory requirements.
- Support the development and maintenance of Standard Operating Procedures (SOPs) and internal training program.
- Conduct internal audits and assist in coordinating external audits to assess compliance with regulatory requirements, Clients' requirements, and Prelude's internal policies and procedures.
- Assist in managing incident tracking, deviations, and CAPAs to ensure timely and proper communication with cross-functional teams, clients, and resolution of issues.
- Support the Verification and Validation (V&V) processes, including the development of related documentation for software products.
- Assist in maintaining compliance with industry regulations, such as 21 CFR Part 11, HIPAA, GDPR, EudraLex Annex 11, and GCP (Human and Animal).
- Contribute to vendor assessments and qualifications to ensure third-party vendors meet compliance and Prelude standards.
- Compile and analyze quality metrics related to compliance activities, providing meaningful insights to assess and improve Prelude’s compliance with regulatory and Client requirements.
- Collaborate with cross-functional teams, including Customer Success, Engineering, Product, DevOps, and Sales & Marketing (as applicable) to support compliance initiatives.
- Provide support in responding to client questionnaires, audits, and surveys related to regulatory compliance activities.
- May serve as a point of contact for internal teams regarding compliance-related queries and assistance in understanding regulatory requirements.
Requirements
- Bachelor's degree in an analytically rigorous field (e.g., Life Sciences, Engineering, etc.).
- 3+ years of experience in a compliance, regulatory, or quality assurance role within a regulated industry (e.g., pharmaceuticals, medical devices, software, healthcare).
- Familiarity with regulations such as 21 CFR Part 11, GCP, HIPAA, GDPR, and ISO 9001.
- Strong organizational skills and attention to detail, with experience managing quality or compliance documentation and processes.
- Strong written and verbal communication skills.
- Ability to work collaboratively in a cross-functional environment.
- Ability to work effectively in a fast-paced environment, with little supervision and be flexible.
- Experience with quality management systems (QMS) and compliance software tools is a plus.
- General knowledge of software development and/or medical product development is preferred.
