Neurocritical Care is a new Minnetronix business and brand focused on developing and delivering solutions to healthcare providers in the Neuro ICU. We are passionate about understanding needs and providing solutions to physicians, patients, and payers.
The Sr. Regulatory Specialist will manage and perform regulatory activities for obtaining product approval/clearance within the Neuro 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.
Essential Duties and Responsibilities:
- Develop, review and support maintenance of regulatory standard operating procedures as applicable.
- 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 Minnetronix Neuro products.
- Serve as a regulatory affairs resource across departments within the organization.
- Bachelor’s Degree + minimum 6years of regulatoryexperienceat a medical device manufacturer.
- Some management experiencepreferred
- R.A.P.S. certification a plus
- Demonstrated knowledge and experience with U.S. and international device regulations
- Demonstrated success in obtaining U.S. product approvals for Class II/III medical devices via 510(k), De Novo or PMA path.
- Expertise with regulatory compliance
- 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
- Ability to interact effectively in a team environment and be able to communicate successfully across a broad audience
- Proficiency in basic personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
- Advanced written and oral communications, technical writing and editing skills
- Strong organizational skills, able to manage multiple projects and timelines
- Proficient knowledge of medical terminology, practices regulations procedures
- Knowledge of clinical trial strategy and study design and general statistical methods
- Able to work through complex problems/projects by exercising independent decision making and utilizing critical and analytical thinking skills and problem-solving skills