Principal Regulatory Affairs Specialist
3 months ago
At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today
We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year
We are looking for an experienced and highly motivated Principal Regulatory Affairs Specialist to join our team and help us develop and demonstrate exciting technologies from ideation through clinical trials.
Position summary: The Principal Regulatory Affairs Specialist is responsible for participating on product development projects, evaluating document change orders for RA assessment, drafting regulatory submissions, and supporting regulatory related projects. The Principal Specialist will develop and implement regulatory strategies to obtain timely approvals for early feasibility studies. From creating regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity to make a difference in people’s lives.
Main responsibilities:
- Lead risk management activities, including the creation and maintenance of risk management documentation, such as FMEAs, hazard analysis, plans, reports, and trace matrices in accordance with ISO 14971 and cybersecurity requirements.
- Participates in development teams and provides input to assure that regulatory requirements are incorporated in the product development process for Class III Medical Devices.
- Create and submit regulatory submissions based on the regulatory strategy
- Review and approve engineering change order documents
- Review promotional material and labeling for regulatory compliance
- Assist with negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval.
- Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports.
- Responsible for product packaging/labeling requirements and ensuring materials conform with applicable regulatory requirements.
- Maintain regulatory documentation and registrations.
- Drive improvements in quality system processes and procedures.
Education/Experience:
- Bachelor’s degree and 8+ years of experience in the medical device industry, Class III preferred
- Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (21CFR820, ISO 13485, and ISO 14971) and audit programs (MDSAP)
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Experienced leading design assurance activities for new product development.
- Critical Thinker, highly organized, efficient and self-motivated
- Experience with SaMD and Digital Health apps
- Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
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