Regulatory Affairs Manager (Medical Device)

Calling all Regulatory Affairs Managers (Medical Device)

  • Irvine, CA
  • $125,000 - $135,000
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A bit about us:

Job Description

The Regulatory Affairs Manager is a key member of the QA/RA team and reports to the VP of QA/RA. The position serves to assist with leading, development, and implementation of all Regulatory imperatives. This job is on-site and requires physical on-site presence.

Why join us?

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Relocation assistance
  • Vision insurance

Job Details

Duties & Responsibilities:

  • Assist in developing and implementing domestic and international regulatory strategies supporting investigational use and commercialization of devices manufactured by us.
  • Promote collaborative, communicative working relationships with regulatory authorities and third-party regulatory service providers
  • Assist in developing a facility-wide understanding of the key elements relating to regulatory compliance requirements
  • Support all aspects of Risk Management
  • Participate in development and maintenance of internal operating policies and procedures relative to Regulatory
  • Assure conformity with domestic and international regulatory requirements

Minimum Qualifications:

  • Bachelor of Science/Engineering
  • 10+ years of RA experience in the medical device industry
  • Knowledge of 21 CFR 820, 2017/745 EU MDR, SOR 98-282, TG(MD)R Schedule 3, ANVISA 16 and ISO 13485
  • Excellent communication skills


Preferred Qualifications:

  • 5+ years of experience with class III tissue based implantable products such as surgical and transcatheter bioprosthetic valves
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Job Details
Managed by Jobot Pro
Location
Irvine, CA
Job Type
Permanent
Compensation
$125,000 - $135,000