Global Regulatory Affairs Specialist for Med Devices & IVD

Selectek, Inc.; Santa Clara (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Selectek, Inc. is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory activities for its diagnostics, life sciences, and laboratory solutions portfolio.

You will develop regulatory strategies, prepare submissions, and ensure ongoing compliance across markets. Responsibilities include coordinating with international teams, maintaining technical files, post‑market surveillance, and driving continuous improvement of regulatory processes across the product

Qualifications

• Bachelor's degree in Life Sciences or regulatory field.
• Minimum 3 years in regulatory affairs within medical devices or IVD.
• Experience with international submissions; RAC preferred.

Responsibilities

• Prepare and submit regulatory documentation for global markets.
• Collaborate with R&D, Quality, and cross-functional teams.
• Maintain Technical Files, GSPR, CER, and risk files.
• Support post-market surveillance and regulatory CAPA.
• Assist with audits and regulatory inspections.

Skills

Regulatory affairs

Global submissions

Cross-functional collaboration

Regulatory strategy

Technical documentation

Education

Bachelor's degree in Life Sciences or regulatory field

Regulatory Affairs Certification (RAC)

Tools

MasterControl

AssurX

Veeva Vault QMS

Job description

Selectek, Inc. is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory activities for its diagnostics, life sciences, and laboratory solutions portfolio.

You will develop regulatory strategies, prepare submissions, and ensure ongoing compliance across markets. Responsibilities include coordinating with international teams, maintaining technical files, post‑market surveillance, and driving continuous improvement of regulatory processes across the product