Sr. Manager Or Assistant Director (Doe) Of Regulatory

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 fast-paced medical device, including start-up environment.
• Bachelors Degree in a scientific discipline
• Ability to review technical/regulatory documents and provide applicable inputs
• Experience of US FDA & CE regulations (preferably with hands-on 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.
Job Type: Full-time
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.