Regulatory Affairs Specialist, Sr.
Description
Essential Functions:
- Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
- Maintains company registrations and device listings in the US, Canada, and the EU.
- Analyzes and reports department metrics.
- Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
- Informs coordinator of product recalls.
- Performs and supports internal, external, and third-party audits.
- Maintains knowledge on current regulations and guidelines.
- Evaluates compliance with applicable regulations, project policies, and procedures
- Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
- Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
- Composes audit plans and reports.
- Conducts audits and inspections of GMP and non-regulated documentation.
- Tracks internal and external corrective and preventive actions.
- 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 negotiation abilities.
- Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
- Demonstrated high standard of quality of work.
- Demonstrated knowledge of FDA 510K 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 analyze and collate data for presentations and reports.
- Ability to prioritize and organize project tasks and goals effectively.
- Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
- Ability to interpret and collate data to present an accurate picture of market potential.
- Ability to research new and emerging technologies and practices.
- Ability to read technical diagrams, graphs, and instructions.
Education and Experience:
- Bachelor’s degree in related field preferred
- Minimum five (5) years of experience in Regulatory Affairs.
Pay Range: $83,898.06 - $120,000.00/YR
Glidewell is an equal opportunity employer, including disability and veteran status.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.