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Ref No.: 19-04992
Category: Clinical Affairs
Location: Sunnyvale, California
Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).

Primary Skills: Documentation, Canada Regulatory, FDA
Duration: 4+ Months (Possible Extension)          
Contract Type: W2 Only

Roles and Responsibilities:
  • Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation.
  • Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets.
  • Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filling justifications,
  • Technical File updates, Canadian License Applications
  • Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
  • Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
  • Perform other duties as required
Skill/Job Requirements:
  • B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred.
  • Non-technical degree with equivalent complex medical device experience acceptable
  • In-depth understanding of FDA, CE mark and Health Canada regulations
  • Ability to work with cross function project teams and understand complex products
  • Ability to work in a fast paced environment and handle multiple projects simultaneously
  • Strong verbal and written communication skills,
  • Proven ability to translate technical documentation into effective regulatory submissions.
  • Ability to review and provide critical feedback on design documentation
  • Able to learn internal procedures and processes and implement the same on project teams.
  • Good interpersonal skills and project management skills.
       To follow up with any questions, please contact Sneha at 408-512-2459.

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Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.