Regulatory Affairs Consultant (IVD/CDx)

MDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world. The Regulatory Affairs Consultant is self-motivated with a proven track record of regulatory clearances. The individual will be tasked to lead regulatory projects, provide strategic regulatory guidance to IVD and CDx clients, and expand relationships with existing clients. The ideal candidate will have an immediate impact and bring a robust network within the CDx community to the position. Primary Responsibilities Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives. Developing FDA Q-subs in collaboration with clients (Pre-subs, Breakthrough, STeP). Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies. Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with assigned Clinical Affairs Scientist and Project Managers. Assist client with product development process as needed. Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc. Interaction with regulatory agencies and clients throughout the submission and review processes. Assist with business development, early client engagement, defining project scopes and supporting development of project proposals. Implementation of regulatory processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures. Collaborate to drive MDC's commercialization strategy to support continued growth. Supports the promotion of MDC through tradeshow attendance, speaking engagements, and other marketing initiatives. Qualifications Bachelor's degree in healthcare or other scientific discipline, required 5+ years of direct IVD regulatory experience, required CDx experience, preferred Quality experience, preferred Requirements Demonstrated consensus building and project leadership skills. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines. Positive team-player. Understanding of U.S. Food and Drug Administration (FDA) laws, regulations and guidance. Understanding of Health Canada Licensing Requirements and the EU IVDR. Understanding of IRB guidelines and Common Rule. Excellent written, verbal, and formal presentation skills. Demonstrated track record of successful regulatory clearances. Strong understanding of IVD and CDx ecosystem required. Excellent organizational, time management, and problem-solving skills. Attention to detail and accuracy in work. Ability to manage competing priorities without compromising quality. Up to 20% travel. Pay Up to $200k OTE including attractive variable compensation program. Employee Stock Options. Benefits Medical, Dental, and Vision Insurance. Health Reimbursement Account (HRA) Flexible Spending (FSA) / Dependent Care Accounts (DCA) Short and Long-Term Disability Group Term Life Insurance 401(k) with Safe Harbor Match Unlimited PTO 13 Paid Holidays Equal Opportunity Employer MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law. We invite you to apply if you have an interest in learning more about MDC and joining our mission to provide diagnostic innovators with the exceptional support and personalized solutions they need to make our world a healthier place.