Functieomschrijving

Functieomschrijving

Regulatory Inquiry Expert

Start Date: ASAP

Duration:1 year

Location: Eindhoven

As a Regulatory Inquiry Expert, your primary responsibility will be to ensure timely and accurate responses to regulatory inquiries received from global Competent Authorities. You will work with a variety of teams, including Complaint Investigators, Business Experts, Clinical Experts, Engineers, and more, to develop responses to inquiries from regulators in accordance with global requirements. Collaborating with Business Experts and Complaint Investigators, you will help determine the necessary information for drafting inquiry responses, ensuring the content meets regulatory requirements.

You will be responsible for reviewing complaints to confirm that all required information for inquiry responses is present. If further investigations are needed, you will track and monitor them to their conclusion. Writing, tracking, and submitting inquiry responses to the necessary authorities will be a key part of your role, alongside improving tracking systems for regulatory inquiry responses. You will also be tasked with performing intake of new inquiries, logging relevant data into tools such as Tracker, Teams, SharePoint, and the complaints database.

You're the Right Fit If You Have:

• Educational Background: A Bachelor's Degree or higher in Biomedical Engineering, Science, Healthcare, or a related field (Associates degree may be considered for candidates with 5+ years of hands-on patient care experience or product servicing/support experience).
• Experience: At least 4 years of experience in Medical Device or another regulated industry. Post Market Surveillance experience in the medical device domain is a plus.
• Experience in Regulatory Roles: 3+ years of experience in biomedical engineering, risk management, quality, or regulatory functions. Alternatively, experience in servicing or supporting products in the field or developing responses to regulatory inquiries will also be considered.
• Regulatory Knowledge: Moderate understanding of Complaint Handling, CAPA, and global medical device regulations, including 21CFR Parts 803, 806, 820, ISO13485, ISO14971, ISO9001.
• Global Post-Market Surveillance: Background in global post-market surveillance regulations such as 21CFR, MDD93/42/EEC, and other applicable regulations.
• Skills: Strong attention to detail, excellent writing skills, and the ability to communicate issues timely and clearly. Proficiency in Microsoft Office applications is essential, with experience using Philips medical devices, Trackwise, and Salesforce as a bonus.

What We Offer

We believe in rewarding your expertise and dedication with a competitive compensation package and excellent benefits. Here's what you can expect:

Primary Employment Conditions

• Market-competitive monthly salary
• 13th-month bonus, paid out periodically
• 8.33% holiday allowance, based on your annual salary

Secondary Employment Conditions

• Pension Plus scheme, securing your future
• €750 net allowance to set up your home office
• 25 vacation days per year (based on a 40-hour workweek)
• Travel allowance for commuting
• Internet allowance to support remote work
• Relocation assistance for candidates moving to the Netherlands

We value work-life balance, personal development, and a great working environment. If you're ready to take the next step in your career, we'd love to welcome you to the team!