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Sr/Principal Regulatory Specialist

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Location
MN
Job Type
Direct Hire
Date
Nov 27, 2018
Job ID
2642433
Our 12-person fully financed neuro start-up client is adding their first Regulatory Specialist to the team! The Sr/Principal Regulatory Specialist will manage and perform regulatory activities for obtaining product approval/clearance within the organization. This role will be primarily responsible for the preparing of U.S. and global (as applicable) regulatory submissions and will work closely with other core team members across the organization.

Your role with the company:

 • Develop and implement approved regulatory and clinical strategies under the direction of the Director of Clinical and Regulatory Affairs.
• Author and/or review appropriate sections of regulatory submissions (including 510(k)s, IDEs, PMAs and PMA supplements) reports or responses.
• Participate or lead when applicable in FDA or other regulatory agency calls or meetings to help establish and maintain a solid, mutually beneficial relationship with them.
• Author and/or review appropriate sections of international regulatory submissions and registrations, as applicable.
• Manage/maintain regulatory submissions and records.
• Perform searches/analyses to address specific regulatory questions or issues.
• Provide direction and oversight to external consultants and other vendors that may be utilized in the execution of regulatory activities.
• Model and drive accountability within the study team (including the extended vendor/contractor team) to meet the goals, timelines and other deliverables associated with execution.
• Work with multidisciplinary project teams to prepare and implement PDP initiatives, clinical development plans, statistical analysis plans and clinical study reports & publications.
• Support the development of content and participate where appropriate in medical, scientific and business advisory board meetings.
• Lead cross functionally, and think creatively when faced with difficult situations related to regulatory processes, PDP execution or team dynamics.
• Support the review and submission of requests for emergency or compassionate use of companies products.
• Serve as a regulatory affairs resource across departments within the organization.

Desired Profile:

 • Bachelor’s Degree + minimum 6 years of regulatory experience at a medical device manufacturer.
•  Demonstrated success in obtaining U.S. product approvals for Class II/III medical devices via 510(k) (required), De Novo or       PMA path.
• Demonstrated knowledge and experience with U.S. and international device regulations
• R.A.P.S. certification a plus
• Self-directed, detail-oriented individual, able to take the initiative, handle ambiguity and accomplish objectives with minimal supervision
• Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
• Occasional travel required (domestic and occasionally international) approximately 10% 
• Expertise with regulatory compliance