Kelly Science, Engineering, Technology & Telecom
Regulatory Affairs Principal, IVD
Kelly Science, Engineering, Technology & Telecom, California, Missouri, United States, 65018
Kelly Science, Engineering, Technology & Telecom provided pay range
This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$60.00/yr - $63.00/yr Position Overview
Kelly Science & Clinical
is recruiting a
Regulatory Affairs Principal
for an
18-month contract
with a leading molecular diagnostics company in Sunnyvale, CA. This role involves translating scientific discoveries into advancements and advancing your career in biotech. Workplace and Position Details
Workplace:
Remote (USA) Position Title:
Regulatory Affairs Principal, New Product Development Pay rate:
$60-63/hour Role Summary
The Regulatory Affairs Principal leads on New Product Development (NPD) teams, working on assay, instrument, software, and system projects. Responsibilities include preparing regulatory submissions, ensuring on-time product launches, and collaborating across functions to introduce new products and foster career growth within Regulatory Affairs. Key Responsibilities
Regulatory Submissions:
Manage submissions for US and EU IVDR and WHO PQ, ensuring compliance and timely launch. Agency Interaction:
Communicate with regulatory agencies and authorities to address queries and obtain approvals. Regulation Interpretation:
Interpret new regulations affecting US and EU markets. Continuous Improvement:
Use DBS tools to improve processes within regulatory domain. Reporting:
Prepare reports and presentations on strategies and project status. Qualifications:
Bachelor's degree with 8+ years, Master's with 6+ years, Doctorate with 3+ years of relevant experience. Project Leadership:
Lead NPD core teams for complex projects. Regulatory Strategy:
Develop strategies for product launches in US, EU, and WHO markets. Documentation:
Prepare regulatory submissions including FDA pre-submissions, 510(k), and PMA. Preferred Qualifications
CLIA waiver experience is a plus. Additional Details
Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Consulting, Quality Assurance, and Science Industries:
Research Services, Biotechnology Research, Medical Equipment Manufacturing Referrals can double your chances of interviewing. Get notified about similar jobs in California, United States.
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This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$60.00/yr - $63.00/yr Position Overview
Kelly Science & Clinical
is recruiting a
Regulatory Affairs Principal
for an
18-month contract
with a leading molecular diagnostics company in Sunnyvale, CA. This role involves translating scientific discoveries into advancements and advancing your career in biotech. Workplace and Position Details
Workplace:
Remote (USA) Position Title:
Regulatory Affairs Principal, New Product Development Pay rate:
$60-63/hour Role Summary
The Regulatory Affairs Principal leads on New Product Development (NPD) teams, working on assay, instrument, software, and system projects. Responsibilities include preparing regulatory submissions, ensuring on-time product launches, and collaborating across functions to introduce new products and foster career growth within Regulatory Affairs. Key Responsibilities
Regulatory Submissions:
Manage submissions for US and EU IVDR and WHO PQ, ensuring compliance and timely launch. Agency Interaction:
Communicate with regulatory agencies and authorities to address queries and obtain approvals. Regulation Interpretation:
Interpret new regulations affecting US and EU markets. Continuous Improvement:
Use DBS tools to improve processes within regulatory domain. Reporting:
Prepare reports and presentations on strategies and project status. Qualifications:
Bachelor's degree with 8+ years, Master's with 6+ years, Doctorate with 3+ years of relevant experience. Project Leadership:
Lead NPD core teams for complex projects. Regulatory Strategy:
Develop strategies for product launches in US, EU, and WHO markets. Documentation:
Prepare regulatory submissions including FDA pre-submissions, 510(k), and PMA. Preferred Qualifications
CLIA waiver experience is a plus. Additional Details
Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Consulting, Quality Assurance, and Science Industries:
Research Services, Biotechnology Research, Medical Equipment Manufacturing Referrals can double your chances of interviewing. Get notified about similar jobs in California, United States.
#J-18808-Ljbffr