Sr. Manager or Assistant Director - Campbell, United States - Vivalnk, Inc

Vivalnk, Inc
Vivalnk, Inc
Verified Company
Campbell, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Benefits:


  • 401(k)
  • 401(k)
matching

  • Bonus based on performance
  • Dental insurance
  • Free food & snacks
  • Health insurance
  • Paid time off
  • Stock options plan
  • Vision insurance

Job description

Qualifications:


  • 10+ years related experience in a fastpaced medical device, including startup environment.
  • Bachelor's Degree in a scientific discipline
  • Ability to review technical/regulatory documents and provide applicable inputs
  • Experience of US FDA & CE regulations (preferably with handson 510K and/or CE submissions), ISO Standards, and GMPs for Medical Devices. Experience on Digital Health and SaMD is strongly preferred.
  • Able to provide thorough, practicable, creative but compliant solutions, consistent with organization objectives, to a wide range of regulatory challenges
  • Demonstrated change management knowledge and skill
  • Experience with regulatory compliance for 21CFR 820, ISO 13485:2016, EU Medical Device Regulation (EU MDR), and other applicable Standards
  • Review and advise on labeling for compliance with regulatory filings
  • Experience with products registration internationally (i.e., Canada, Latin America, Europe, Japan, Asia, and. per request)
  • Proficiency in Words, Excel, Power Point
  • Impeccable attention to detail and organization skills
  • Demonstrate excellent people skills
  • RAC certificate is a plus

Responsibilities:


  • Provide regulatory support to customers about company products/services.
  • Closely involve or host audits from customers.
  • Closely involve or lead regulatory submissions ( FDA or CE)
  • Closely involve or responsible for regulatory registration internationally.
  • Participate in audits from regulatory agencies & FDA.

Salary:
$150,000.00 per year


Benefits:


  • 401(k)
  • 401(k)
matching

  • Dental insurance
  • Health insurance
  • Paid time off
  • Stock options
  • Vision insurance

Experience level:

  • 10 years

Work Location:
Hybrid remote in Campbell, CA 95008

Flexible work from home options available.
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