Job Summary:

The Principal Regulatory Affairs (RA) Specialist will work with the team to support the Regulatory Affairs department to ensure the overall regulatory compliance with the applicable regulatory bodies and ensure compliance with the Presidio Quality Management System (QMS). The Principal Regulatory Affairs Specialist is responsible for participating on design control projects, evaluating document change orders for RA assessment, evaluating design change forms for RA assessment, drafting regulatory submissions, review and sign off on Regulatory/Quality documents, i.e., NCRs, CAPAs, PRAs, etc. Assist in planning of regulatory related projects in alignment with company goals.

Essential Duties and Responsibilities:

• Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.
• 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.
• Work with R&D on Risk Management and review and approve Risk Management File(s).
• Responsible for compilation of Class III medical device Regulatory submissions (IDE/supplements, PMA/supplements, Design Dossier, and any required international submissions.
• Responsible for review/approval of Document Change Orders (DCOs), Design Change requests and labeling; including assessments of regulatory impact.
• Responsible for Change notifications to notified body and any additional regulatory notifications.
• Reviews Clinical reported events during the clinical study are documented, logged, and tracked accordingly and evaluated 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.
• Assists with internal audits and external audits, driving issues to closure as required.
• Responsible for product packaging/labeling requirements and ensuring all materials are conforming with applicable regulatory requirements.
• Maintain regulatory documentation, registrations and device listings both domestic and international markets.
• Review and interpret regulatory rules and ensure that 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.
• Other duties as assigned.

Qualification Requirements:

Experience:

• A minimum of 10 years of experience in Regulatory Affairs, 8 with Masters 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.

Physical Demands:

• Varied sitting, standing, and walking.
• Ability to lift and carry 50lbs. or less.