Regulatory Affairs Specialist, Sr.

Prismatik; Irvine (CA); On-site; USD 83,898 - 120,000; Full time

Job summary

A leading healthcare technology company in Irvine, California is seeking an experienced Regulatory Affairs professional. This role involves preparing and submitting product registrations, maintaining compliance with federal and state regulations, and managing audits. Applicants should have a bachelor's degree in a related field and at least five years of experience in Regulatory Affairs. Proficiency in MS Office Suite and strong analytical skills are essential. Compensation ranges from $83,898.06 to $120,000.00 per year.

Qualifications

• Minimum five (5) years of experience in Regulatory Affairs.
• Demonstrated high standard of quality of work.
• Ability to analyze and collate data for presentations and reports.

Responsibilities

• Prepare and submit product registrations to FDA and other regulatory bodies.
• Maintain knowledge of current regulations and guidelines.
• Conduct audits and inspections of documentation.

Skills

MS Office Suite (Excel, Word, PowerPoint, Outlook)

Quantitative and analytical skills

Negotiation abilities

Knowledge of FDA 510K and ISO 13485 Standards

Attention to detail

Education

Bachelor’s degree in related field

Job 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