Regulatory Affairs Consultant - IVD/CDx

3 days ago

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MDC Associates, Inc.

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Supporting IVD innovators with RA/QA/CRO, FDA/CE IVD Submission, Training, Go-to-Market support and more.

regulatory • diagnostics • point of care • FDA • IVDR

11 - 50

Description

• Provide 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.

Requirements

• Bachelor's degree in healthcare or other scientific discipline, required • 5+ years of direct IVD regulatory experience, required • CDx experience, preferred • Quality experience, preferred • Demonstrated consensus building and project leadership skills. • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements. • 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.

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