Regulatory Affairs Specialist

2 weeks ago

San Mateo, California, United States Presidio Medical, Inc. Full time
Job Summary:

The Principal Regulatory Specialist will play a key role in ensuring the overall regulatory compliance of Presidio Medical, Inc. with applicable regulatory bodies and the Presidio Quality Management System (QMS). This position will work closely with the Regulatory Affairs department to evaluate design control projects, document change orders, and design change forms for regulatory assessment. The successful candidate will also be responsible for drafting regulatory submissions, reviewing and signing off on regulatory/quality documents, and assisting in the planning of regulatory-related projects.

Essential Duties and Responsibilities:
  • Collaborate with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.
  • Work with R&D on product V&V activities, including sterilization, packaging/labeling, transit testing, real-time/accelerated aging, and review/approval of engineering protocols and reports.
  • Responsible for compilation of Class III medical device Regulatory submissions (IDE/supplements, PMA/supplements, Design Dossier, and any required international submissions).
  • Review/approve Document Change Orders (DCOs), Design Change requests, and labeling, including assessments of regulatory impact.
  • Responsible for Change notifications to notified bodies and any additional regulatory notifications.
  • Review Clinical reported events during clinical studies, document, log, and track accordingly, and evaluate for regulatory reporting requirements.
  • Responsible for Regulatory sign-off of Product Release approvals for shipment of Presidio materials.
  • Responsible for review and sign-off on NCRs, CAPAs, etc. for regulatory signature.
  • Assist with internal audits and external audits, driving issues to closure as required.
  • Responsible for product packaging/labeling requirements and ensuring all materials conform to applicable regulatory requirements.
  • Maintain regulatory documentation, registrations, and device listings for domestic and international markets.
  • Review and interpret regulatory rules and ensure they are communicated through company policies and procedures.
  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
  • Write/revise departmental SOPs as required.
  • Provide guidance and direction to subordinate regulatory personnel to assist in personal and professional development.
  • Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
  • Comply with all health and safety regulations, policies, and work practices.
Qualification Requirements:
  • A minimum of 10+ years of experience in Regulatory Affairs, 8+ with a Master's degree.
  • 5+ years' experience in the Medical Device industry, preferably Class III active medical devices.
  • Regulatory Affairs Certification expected (US).
  • Experience with design controls, including mechanical, software/firmware, and risk management review.
  • Experience with FDA IDE, PMA, and Australia submissions.
Knowledge/Skills/Abilities:
  • Knowledgeable of FDA (21CFR 812, 820), ISO 13485, and ISO14971.
  • Thorough understanding of FDA and applicable international regulations.
  • Excellent written and oral communication, and technical writing and editing skills.
  • Ability to write clear and understandable technical documentation.
  • Skilled at analyzing and summarizing data.
  • Ability to manage and prioritize multiple projects.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Understanding of design verification and validation methods.
  • The ability to work independently with minimal supervision.
  • Extreme attention to detail.
  • Excellent problem-solving skills.
  • Excellent interpersonal skills and a spirit of teamwork.
Education:
  • Bachelor of Science in an Engineering or Scientific similar field.

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