Regulatory Affairs Specialist - Senior

Company: Yoh
Location: West Sacramento
Posted on: September 13, 2023

Job Description:

Senior Regulatory Affairs Specialist (remote)Pay: $40-46/hourContractThe Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports our clients regulatory programs. The incumbent's primary responsibilities will be the evaluation, coordination, preparation, and implementation of post-market Regulatory Affairs activities. Responsibilities may include:

• Administration of the company's complaint management program for compliance with corporate requirements.
• Planning and implementing pre-market registration, reporting, and compliance activities in accordance with the development center business plans.
• Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments. Additionally, may provide assistance to technical departments, manufacturing business centers, and suppliers in the creation and structuring of clinical data for pre-market notifications.
• Functioning as a team expert for promotional materials review, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of medical devices.Educational Requirements:
  • Bachelor's degree in a related field with 5+ years of experience OR
  • Master's degree in a related field with 3+ years of experience.
  • Medical Technologist background and IVD experience strongly desired.Note: Any pay ranges displayed are estimations.-- Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.-- All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit--to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, West Sacramento , Regulatory Affairs Specialist - Senior, Other , West Sacramento, California