Regulatory Affairs Specialist 4

eTeam Inc.

Sunnyvale, CA

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JOB DETAILS

SALARY

$58–$59 Per Hour

SKILLS

Communication Skills, Document Management, Documentation, FDA (Food and Drug Administration), Health Canada, Input/Output, Interpersonal Skills, Manufacturing/Industrial Processes, Market Analysis, Medical Equipment, Multitasking, Negotiation Skills, Presentation/Verbal Skills, Product Control, Product Design, Product Lifecycle Management, Product Reviews, Product Testing, Regulations, Regulatory Submissions, Risk, Risk Management, Team Player, Technical Writing, Validation Testing, Writing Skills

LOCATION

Sunnyvale, CA

POSTED

7 days ago

Title: Regulatory Affairs Specialist 4
Location: Sunnyvale, CA - Hybrid (3 days per week onsite)
Duration: 6 months

Description:

Primary Function of Position
The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses.

Essential Job Duties
" Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
" Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
" Author and lead regulatory documentation and submissions, including U.S. FDA 510(k)
premarket notifications, internal Letters to File, , pre-submissions, Health Canada submissions with minimal supervision.
" Coordinate with technical experts to provide additional data/information requested by
regulatory agencies and prepare responses to facilitate regulatory approvals.
" Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-
functional alignment and resolution.
" Collaborate with international counterparts to support global regulatory submissions,
approvals, and implementation rollouts.

Required Skills and Experience
" Minimum 8 years of regulatory affairs experience working in a medical device company
(can be in combination with a regulatory affairs master degree; e.g., Masters in
Regulatory Science)
" In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.
" Regulatory working knowledge of product lifecycle management, design controls, risk
management, verification and validation, and product labeling requirement
" Ability to work in a fast-paced environment and handle multiple projects simultaneously

" Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
" Team player who seeks to help and learn from colleagues seeing the department success as their own
" Strong interpersonal and negotiation/influencing skills while maintaining a high level of
professionalism
" Proactively seeks to develop and become well-versed within the regulatory landscape.

Required Education and Training
Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical
Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

Preferred Skills and Experience
" RAPS Regulatory Affairs Certification (RAC) is a plus.

About the Company

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Other/Not Classified

FOUNDED

1998

WEBSITE

www.eteaminc.com

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