What are the responsibilities and job description for the Regulatory Affairs Specialist position at Prismatik?
Essential Functions:
- Serves as Regulatory Affairs subject matter expert (SME) on designated projects and product development to ensure compliance through all phases of development.
- Provides project and product guidance, feedback, and recommendations as necessary to support compliance.
- Participates in development meetings and collaborates with appropriate project teams on any issues of non-compliance.
- Determines requirement and prepares and submits company registrations for State Licensing/Permits accordingly.
- Prepares, submits, and oversees designated product registrations and (510(k)) submissions to FDA and other regulatory bodies.
- Prepares, submits, and oversees designated domestic and international submissions.
- Serves as point contact for FDA, regulatory bodies, and various agencies during submission processing and review to resolve inquiries and increase approval effort.
- Serves as co-author for 510(k) submissions, partnering with appropriate team members on complex submission and providing insight as necessary to support clearance.
- Monitors compliance with existing regulations/standards/guidance and upcoming or changing regulations/standards/guidance.
- Reviews and approves design control documents.
- Evaluates compliance with applicable regulations, project policies, and procedures.
- Reviews and writes standard operating procedures (SOPs) and other RA policies as necessary.
- Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
- Coordinates with international regulatory team members regarding product changes and regulatory notification and/or approval requirements.
- Provides management with ideas for developing and implementing strategies and processes.
- Reviews and approves advertisements, labels, and public communication documents for regulatory compliance.
- Reports significant regulatory issues related to a product’s release to appropriate parties.
- Evaluates product compliance to applicable regulations and project requirements.
- Participates in FDA facility inspection, Notified Body audits, and other government inspections as needed.
- Maintains RA related files.
- Maintains company registrations and device listings in the US, Canada, and other countries.
- Performs other related duties and projects as business needs require at direction of management.
Knowledge and Abilities:
- Proficient knowledge of general office procedures.
- Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
- Proficient quantitative and analytical skills.
- Demonstrated prioritization and time management skills.
- Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
- Demonstrated high standard of quality of work.
- Demonstrated knowledge of FDA 510(k) and ISO 13485 Standards.
- Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg. Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
- Demonstrated reliability, dependability, and flexibility in work habits.
- Demonstrated attention to detail and accuracy.
- Ability to prioritize and organize project tasks and goals effectively.
- Ability to maintain confidentiality, exhibiting high level of integrity,
Education and Experience:
- Bachelor’s degree in related field preferred, but not required.
- Minimum two (2) years of experience in Regulatory Affairs.
- Experience preparing (writing) domestic and international product submissions, required.
Pay Range: $68,000 - $90,000/YR
Salary : $68,000 - $90,000
