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Regulatory Affairs Specialist (Contractor)

Job Description

Regulatory Affairs Contractor
Santa Clara, CA
 
  • Manages regulatory responsibilities associated with the development, support, and deployment of the Company's non-medical and medical device software products.
  • Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
  • Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company's products.
  • Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims.
  • May serve as a contact with affiliates to achieve international registration of products.
  • Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
  • Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.
Minimum Qualifications:
  • Bachelor's degree or equivalent
  • 6+ years of related Regulatory Affairs experience
  • Working knowledge of software and software development
  • Proficient in MS Office applications
Highly Preferred Qualifications:
  • Master's degree/PhD. or equivalent (preferred)
  • US FDA Class I, II and III medical device experience
  • EU MDD experience
Soft Skills Needed:
  • Excellent oral and written communication skills
  • Consistently neat and accurate reporting
  • High attention to detail
  • Excellent organizational skills
  • Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization

Job Requirements

 

Job Snapshot

Location US-CA-Santa Clara
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Energy, Oil & Gas, Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Santa Clara
Sachin Saini
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Snapshot
Ascent
Company:
US-CA-Santa Clara
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Energy, Oil & Gas, Other
Store Type:

Job Description

Regulatory Affairs Contractor
Santa Clara, CA
 
  • Manages regulatory responsibilities associated with the development, support, and deployment of the Company's non-medical and medical device software products.
  • Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
  • Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company's products.
  • Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims.
  • May serve as a contact with affiliates to achieve international registration of products.
  • Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
  • Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.
Minimum Qualifications:
  • Bachelor's degree or equivalent
  • 6+ years of related Regulatory Affairs experience
  • Working knowledge of software and software development
  • Proficient in MS Office applications
Highly Preferred Qualifications:
  • Master's degree/PhD. or equivalent (preferred)
  • US FDA Class I, II and III medical device experience
  • EU MDD experience
Soft Skills Needed:
  • Excellent oral and written communication skills
  • Consistently neat and accurate reporting
  • High attention to detail
  • Excellent organizational skills
  • Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization

Job Requirements

 
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Regulatory Affairs Specialist (Contractor) Apply now