Regulatory Affairs Specialist 3 – Medical Device, IVD

Grifols

Regulatory Affairs Specialist III at Grifols developing regulatory strategies for IVD products. Collaborating cross-functionally and mentoring juniors in a fast-paced healthcare environment.

Posted 4/27/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $105,800 - $132,250 per yearWebsite

About the role

Key responsibilities & impact

Ensure regulatory compliance and support global market access for IVD products
Develop and execute regulatory strategies
Prepare and submit complex pre-market and post-market applications to FDA, EU Notified Bodies
Manage communications with health agencies
Collaborate with cross-functional teams
Provide regulatory input throughout the product lifecycle
Mentor junior colleagues
Monitor evolving regulations to identify risks and implement mitigation plans

Requirements

What you’ll need

Bachelor’s degree in life sciences, engineering, or a related field
At least 6 years of experience in a regulated environment
4 years of direct experience in Regulatory Affairs
Prior experience in the IVD or Drug/Biologics industry
Strong technical expertise
Analytical skills
Ability to influence stakeholders
Exceptional computer skills in Microsoft Office, Adobe, Excel
Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA

Benefits

Comp & perks

Medical
Dental
Vision
PTO
up to 5% 401(K) match
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory complianceregulatory strategiespre-market applicationspost-market applicationsregulatory inputrisk mitigationanalytical skillstechnical expertise

Soft Skills

communicationcollaborationmentoringinfluencing stakeholders