Job Summary:

We are seeking a highly motivated Regulatory Affairs Specialist to support the Regulatory Affairs department in ensuring compliance with the Presidio Quality Management System (QMS) and applicable regulatory bodies. In this role, you will be responsible for the tactical execution of regulatory tasks, including evaluating design changes, submission compilation, and ensuring product development activities meet FDA and global regulatory requirements.

Essential Duties and Responsibilities:

  • Support drafting and maintenance of Class III Software medical device regulatory submissions (IDE and international filings) under supervision of senior staff in accordance with applicable standards and guidance.
  • Review, provide input and approve technical documentation related to Verification & Validation activities per the required standards including ISO 14708, ISO 60601, IEC 62304, etc.  and Risk Management Files (ISO 14971).
  • Support creation and review of product labeling and internal labeling systems to ensure compliance with relevant regulatory requirements.
  • Review and approve design, labeling, and manufacturing changes, providing thorough assessments of regulatory impact throughout product lifecycle.
  • Ensure product compliance to applicable regulatory requirements and support Regulatory sign-off for product release.
  • Assist in maintaining regulatory documentation, device listings, and registrations for domestic and international markets.
  • Support internal and external audit activities.
  • Write and revise departmental SOPs to maintain alignment with current regulations.
  • Stay current with domestic and international regulations and standards to support implementation strategies.
  • Comply with all health and safety regulations and adhere to the Presidio Quality Management System requirements.
  • Other activities as assigned.

 

Qualifications:

  • Education: Bachelor of Science in Engineering or a related Scientific field.
  • Experience: Minimum of 3+ years in the Medical Device industry (Class III active medical devices preferred)
  • Certification: Regulatory Affairs Certification (RAC) is strongly preferred.
  • Core Skills:
    • Knowledge of FDA regulations (21 CFR 812, 820) and ISO standards (13485:2016, 14971:2019, 60601-1-11:2015, 14708-1;2014, 14708-3:2017).
    • Experience with design controls, risk management, and verification/validation methods.
    • Strong technical writing, editing, and analytical skills.
    • Ability to manage multiple projects with high attention to detail.
    • Excellent interpersonal and communication skills with a spirit of teamwork.

 

Salary Range:

$70,000.00 - $90,000.00

The final salary offered will be determined based on the candidate's professional experience, qualifications, and geographic location.

Note:
This role is not sponsorship eligible.
This role is based in San Mateo, CA