Introduction

What are you going to do 

Our client is a fast-growing and stable Medical Devices MNC, with a strong product pipeline

Regulatory Strategy: Develop and implement regulatory strategies to support the registration and approval of medical devices in domestic and international markets.

Regulatory Submissions: Prepare, review, and submit regulatory dossiers, including 510(k)s, premarket approval applications (PMA), CE Mark applications, and other submissions, ensuring accuracy and completeness.

Product Classification: Determine the appropriate regulatory pathway and classification for new and existing medical devices.

Labeling and Packaging: Review and approve product labeling, packaging, and marketing materials to ensure compliance with regulatory requirements.

Post-Market Surveillance:Support post-market surveillance activities, including adverse event reporting, field actions, and product recalls, as necessary.

Regulatory Intelligence: Stay informed about changes in medical device regulations, guidelines, and standards, and communicate relevant updates to the organization.

Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to provide regulatory guidance and support throughout the product lifecycle.

Regulatory Audits:Prepare for and participate in regulatory agency audits, inspections, and notified body assessments.

Training and Guidance: Provide training and mentorship to junior members of the regulatory affairs team and other relevant departments.

(Registration Number: 199603098R | Company License Number : 16S8067 Consultant License Number R2198025.)

Essential skills and knowledge

What we offer 

Are you the perfect match for this vacancy? Apply in 5 minutes and let's get in touch!

your-application-process[1]

Process of your application

Application process & contact

We will now begin examining your application: We will take a close look at your application documents and ask you for additional information if necessary. If your qualifications match our requirements, we will invite you to meet us for the first time.

Project discussion with our customer

If the introductory meeting goes well for you and us, we will arrange a meeting with the customer who has the perfect project for you. This gives you the opportunity to find out more about the customer and the project.

The decision

If you enjoyed the project discussion and the customer is also convinced of your expertise, we will ask you the final and decisive question: Do you want to get started at Brunel?

Introductory conversation with Brunel

In an introductory meeting, we would like to find out more about your interests, ambitions and professional developments. At the same time, we report on working at Brunel and provide information about all career opportunities and prospects.

Welcome to Brunel

Now great times are beginning! With Brunel you have countless opportunities to help shape technological progress. You decide how your career path goes. We support you in every phase of your career. You always have security behind you: Brunel!