Principal Specialist, Regulatory Affairs
Principal Specialist, Regulatory Affairs - Permanent - Denver, CO
Proclinical is seeking a Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI / ML with their location in the Denver, CO area.
Primary Responsibilities :
In this role, you will lead regulatory strategies for new medical technology products and support numerous 510(k) applications.
The position will be based at their Colorado site in a hybrid work schedule.
Skills & Requirements :
- Accomplished Regulatory professional with extensive experience forged within the Medical Devices sector dealing with the major regulators (FDA, EU NBs, etc.).
- 8+ years of experience in Regulatory Affairs with SaMD, SaaS, or embedded software products. Preferably with AI / ML and / or imaging product experience
- Solid basis in scientific approach and an ability to deal with in-depth technical information from a variety of disciplines;
foster a high degree of scientific credibility with regulatory agencies and internal stakeholders.
- Excellent oral and written communication skills. Written skills include 510(k) and other regulatory filings worldwide.
- Previous Success in registering software as a medical device (SaMD, SaaS).
The Principal Specialist, Regulatory Affairs will :
Lead regulatory strategies for new medical technology products / business areas using advance technologies including AI / ML in the clinical imaging and workflow markets;
these indications provide improved clinical outcomes for thousands of patients worldwide. You will work closely with R&D and Clinical to drive validation strategies and clinical protocols.
- Contribute to continual development of the company’s regulatory strategy in support of company objectives.
- Establish and maintain industry-leading practices and documentation for regulatory and other excellence in medical device applications including SaMD / SaaS applications.
- Support, in conjunction with the QA group, the development / refinement of internal systems for regulatory compliance in alignment with the company’s evolving growth and operating phases.
- Plan and execute successfully and efficiently all FDA and other regulatory and compliance activities related to the assigned areas of responsibility.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Director/Principal Specialist, Regulatory Affairs
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO. Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area. The Directo...
Regulatory Affairs Specialist - Contract
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
Principal Medical Affairs Specialist.
When working with Medtronic legal administrative professionals, paralegals, e-discovery specialists, and in-house counsel, the Principal Medical Affairs Specialist will serve as an integral part of the legal team, sharing specialized knowledge of medicine and of Medtronic products. This position, Pr...
Global Regulatory Affairs Specialist
A company is looking for a Global Regulatory Affairs Specialist. ...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the following:. Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant with th...
Principal Biologist/Regulatory Specialist (Principal Level)
Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Project Controls Manager
Reporting to the Project Director, the Controls Manager is responsible for drafting, managing, and maintaining project related contracts, creating and maintaining the project schedule, material/equipment/service bidding and procurement, monitoring the financial health of the project and developing r...
Senior Project Manager Electric Utilities
In this role, you will work alongside engineering managers and account managers to provide Project Management Services supporting various. Additionally, you will lead larger proposals, manage a team of project managers, and ensure the successful delivery of projects while adhering to Leidos' Mission...
Clinical Science Program Manager
Job Title: Clinical Science Program Manager. The UCARE team is seeking applications for a Research Services Clinical Sciences Program Manager. Are you interested in supporting an internationally recognized program performing cutting edge clinical research in a highly stimulating academic environment...
Sr. Trade Compliance Specialist
Trade Compliance Specialist coordinates the tactical aspects of export and import licensing and acts as a Business Group Subject Matter Expert in Trade Compliance functions in accordance with U. Supports Contract Operations team by reviewing customer/supplier contracts and providing recommended chan...