MDC Associates, Inc.
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
Regulatory Affairs Consultant - IVD
May 19
MDC Associates, Inc.
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
• Lead regulatory projects and provide regulatory guidance to IVD device manufacturers • Responsible for the overall planning of regulatory activities • Provide input on clinical study design and reports for CRO services team • Develop and implement strategies in a collaborative environment between colleagues and clients for successful regulatory submissions
Requirements
• Bachelors degree in healthcare or other scientific discipline or educational equivalent • 5-10 years of IVD Regulatory Affairs experience with Clinical Trial Management as a plus • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements • Understanding of U.S. Food and Drug Administration (FDA) laws, regulations and guidances • Understanding of Health Canada Licensing Requirements and the EU IVDR • Understanding of IRB guidelines and Common Rule
Benefits
• Salary + Bonus • Equity Plan • Medical, Dental, and Vision Insurance • Flexible Spending / Dependent Care Accounts • STD/LTD/GTL/VTL • 401(k) w/ match potential • Generous PTO / Sick time policy
Apply NowSimilar Jobs
May 8
Anchorage Digital
201 - 500
🇺🇸 United States – Remote
💵 $95k - $130k / year
💰 $350M Series D on 2021-12
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🗽 H1B Visa Sponsor
April 29
April 29
April 11
firsthand
51 - 200
March 29
DeepHealth
11 - 50