Biocompatibility Regulatory Compliance Analyst / Medical Device

ISO 10993, Regulatory, Biocompatibility Regulatory Compliance
Full Time
$90,000 - $120,000
Work from home not available Travel required to 10%.

Job Description

Please note I have direct access to the Hiring Director of Regulatory Affairs on this position.

Company will transfer existing Visas

Relocation Assistance available

An International, successful, extremely profitable and the largest global privately held medical software/hardware Company is looking for Biocompatibility Regulatory Compliance Analyst. The company is privately held, has been in business for 65+ years, has $1+ Billion in revenue, has 5K+ employees, is extremely profitable and has never laid-off an employee.

The Biocompatibility Regulatory Compliance Analyst will work alongside Global R&D, Product Management, Manufacturing Engineering, Quality Management and Regulatory affairs in providing support and guidance regarding regulatory compliance as it pertains to the biocompatibility of medical devices. More specifically, the Biocompatibility Regulatory Compliance Analyst will:

  • Determine regulatory requirements/status for new/proposed products in material biocompatibility and other related areas.
  • Determine appropriate level of product pre-clinical safety testing based on international standards and regulatory requirements associated with biocompatibility and toxicology.
  • Provide technical expertise and support to the Regulatory submission team on obtaining marketing clearance for all Global medical devices, with regard to biocompatibility certifications.
  • Evaluate changes in existing medical devices products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market in accordance with current global, federal and state standards.

The Biocompatibility Regulatory Compliance Analyst reports to the Director of Regulatory Compliance.

REQUIREMENTS

  • Must have experience with ISO 10993 and evaluating the biocompatibility of medical devices
  • Bachelor s degree in Toxicology, Chemistry, Chemical Engineering, Material Science, Engineering or related degree
  • It would be a plus (not mandatory) to have any working knowledge of standards and regulations such as: ISO 13485, 21 CFR 58, FDA Guidance Documents for biocompatibility, ISO 14001 and/or ISO 9001

The company offers full benefits (PPO & HMO) including dental and vision, matching 401K, 3 weeks of vacation, paid sick days, Short and Long-Term Disability, Life Insurance, Tuition reimbursement, casual dress and flexible work hours that all start upon employment.

Posted By

Al Karaptian

Hermosa Beach, CA, 90254

Dice Id : equest
Position Id : 6098634
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