Regulatory Inquiry Expert, Randstad

Randstad

Location:

Netherlands, Eindhoven

Category:

IT - Administration

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

As a Regulatory Inquiry Expert, ensure compliance with global requirements, collaborate with multidisciplinary teams, draft and submit responses to regulatory inquiries, monitor investigations, and improve tracking systems for regulatory responses.

Job Responsibility:

Ensure timely and accurate responses to regulatory inquiries received from global Competent Authorities
Develop responses to inquiries from regulators in accordance with global requirements
Collaborate with Business Experts and Complaint Investigators to determine the necessary information for inquiry responses
Review complaints to confirm all required information for inquiry responses is present
Track and monitor investigations to their conclusion
Write, track, and submit inquiry responses to necessary authorities
Improve tracking systems for regulatory inquiry responses
Perform intake of new inquiries
Log relevant data into Tracker, Teams, SharePoint, and complaints database

Requirements:

Bachelor’s Degree or higher in Biomedical Engineering, Science, Healthcare, or a related field
Associates degree with 5+ years of hands-on patient care experience or product servicing/support experience
At least 4 years of experience in Medical Device or another regulated industry
Post Market Surveillance experience in medical device domain is a plus
3+ years of experience in biomedical engineering, risk management, quality, or regulatory functions
Moderate understanding of Complaint Handling, CAPA, and global medical device regulations
Background in global post-market surveillance regulations
Strong attention to detail
Excellent writing skills
Proficiency in Microsoft Office applications

Nice to have:

Experience using Philips medical devices
Experience with Trackwise
Experience with Salesforce

Additional Information:

Job Posted:

April 04, 2025

Expiration:

April 04, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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