Sr. Regulatory Affairs - Contract

TalentBurst, Inc.

Sunnyvale, CA

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JOB DETAILS

SKILLS

Biomedical Engineering, Communication Skills, Document Management, Documentation, Electrical Engineering, FDA (Food and Drug Administration), Health Canada, Input/Output, Interpersonal Skills, Manufacturing/Industrial Processes, Market Analysis, Mechanical Engineering, Medical Equipment, Multitasking, Negotiation Skills, Pharmacy, 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

Today

Job Title: Sr. Regulatory Affairs
Location: Sunnyvale, CA - Hybrid
Duration: 06 Months

Onsite: Onsite 3 Days Per Week

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.

Working Conditions
None

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

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About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/

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