Position: Part-Time Regulatory Affairs Consultant (100% Remote)
Location: Madison, WI
Duration: 8 months with strong likelihood of extension
Start Date: March 1, 2021
Our client provides novel search, analytics, and imaging solutions to healthcare enterprises with it's flagship Therapy Response Module. The company offers clinicians with real-time evidence-based imaging insights that aid in decision making for patient care and reduced delivery cost. While the module addresses many of the needs in therapy response assessments for cancer screening in hospitals, it lacks some fundamental workflow needs to transfer to pharmaceutical companies and clinical research organizations to assist in clinical trials. We are in search of a consultant who can assist in implementing the product at life sciences and clinical research organization markets.
We are search of a consultant who has managed regulatory compliances in a pharmaceutical company and/or a clinical research organization in order to develop the necessary functionality and value proposition for these markets.
- SaMD (software as a medical device) specific assessment and optimization of existing process and quality record generation for small companies
- Strong knowledge of both US and EU regulatory guidelines for AI and machine learning
- Assessment and creation of quality records for legacy software
- Using electronic quality record systems (JIRA, SharePoint)
- Auditing by BSI
Ideally will be:
- Actively involved in the ongoing FDA effort to codify the artificial intelligence and machine learning framework and pre-certification
- Experienced with the application of HITRUST in the context of a SaMD Quality Management System
- Experienced with auditing by DEKRA
Experience specific with but not limited to the following standards/regulations/guidance:
- ISO 9001
- ISO 13485:2016
- MDD 93/42/EEC
- MDR 2017-745
- IMDRF /SaMD WG/N23 FINAL: 2015 Software as a Medical Device (SaMD): Application of Quality Management System
- FDA 21 CFR parts 11, 820
- ISO 14971:2019 (2012 for EU)
- IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
- IMDRF/SaMD WG/N41FINAL:2017 Software as a Medical Device (SaMD): Clinical Evaluation
- ISO 62304:2006
- IMDRF/CYBER WG/N60FINAL:2020 Principles and Practices for Medical Device Cybersecurity
- MDCG 2019-16 Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software 14JAN2005
- Advise the company in regulatory standards
- Serve as the primary contact for FDA submissions and approvals
What's In It For You?:
The opportunity to work at one of the fastest growing Top 10 technology startups in Madison, WI. This is a 100% remote, contract opportunity where you have the chance to use your skills to help launch a new product in groundbreaking medical and scientific trials.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.