Industrial Machinery Manufacturing

EVIDENT Europe GmbH

1001-5000

Germany

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

The **Senior Regulatory Affairs Project & PMS Manager (m/f/d)** will lead regulatory planning and execution for IVD and medical devices throughout new product development and post-market phases. This role ensures global regulatory compliance, creates and implements regulatory strategies, and maintains technical documentation and submissions for international markets. The position also acts as the key contact with global health authorities, securing market access for innovative products.

## Tasks

*   **Regulatory Strategy and Planning:** Develop and execute regulatory plans, provide guidance, and conduct impact assessments.
*   **Technical Documentation:** Create and maintain technical documentation, collaborating with R&D, Quality, and Clinical teams.
*   **Global Submissions:** Prepare and manage registration dossiers, coordinate filings, and monitor regulatory updates.
*   **Regulatory Interactions:** Act as the primary contact for regulatory meetings and communications.
*   **Project Management:** Manage regulatory deliverables, coordinate teams, and ensure alignment with project plans.
*   **PMS Management:** Develop and maintain PMS systems, design and execute plans, and oversee regulatory documents.
*   **Adverse Event Reporting:** Manage investigations and reporting of adverse events, lead root cause analysis, and maintain records.
*   **Data Analysis:** Analyze PMS data, collaborate on evaluations, and ensure alignment with the QMS.
*   **Global Compliance:** Monitor global PMS requirements, provide guidance, and support audits and submissions.

## Requirements

*   **Education:** Bachelor's degree in life sciences, biomedical engineering, regulatory affairs, or related field. Certification in regulatory affairs or project management is a plus.
*   **Experience:** 7-10 years in regulatory affairs for IVD or medical devices, with experience in NPD and global submissions. Proven track record in regulatory submissions and interactions with authorities.
*   **Skills:** Understanding of global regulatory frameworks, project management, analytical and problem-solving skills, strong communication, collaborative mindset, proficiency in PMS tools, and knowledge of risk management principles.

## Benefits

*   Flexible working hours, 50% remote work possible   
*   30 days of holiday per year
*   13,5 salaries a year
*   Modern office and inspiring working environment
*   Subsidized meals in the neighborhood of our office (Stadtküche)
*   Public transport ticket (100% subsidized) or free parking space
*   Bike leasing
*   Subsidy fitness first gym
*   Employee Assistance Program to support your health, mental and emotional well-being
*   Comprehensive company pension scheme
*   Joint company events and activities

Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

Employee

Professional / Experienced

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.
The Senior Regulatory Affairs Project &amp; PMS Manager (m/f/d) will lead regulatory planning and execution for IVD and medical devices throughout new product development and post-market phases. This role ensures global regulatory compliance, creates and implements regulatory strategies, and maintains technical documentation and submissions for international markets. The position also acts as the key contact with global health authorities, securing market access for innovative products.
<h2 id="tasks">Tasks</h2>
<ul>
<li>Regulatory Strategy and Planning: Develop and execute regulatory plans, provide guidance, and conduct impact assessments.</li>
<li>Technical Documentation: Create and maintain technical documentation, collaborating with R&amp;D, Quality, and Clinical teams.</li>
<li>Global Submissions: Prepare and manage registration dossiers, coordinate filings, and monitor regulatory updates.</li>
<li>Regulatory Interactions: Act as the primary contact for regulatory meetings and communications.</li>
<li>Project Management: Manage regulatory deliverables, coordinate teams, and ensure alignment with project plans.</li>
<li>PMS Management: Develop and maintain PMS systems, design and execute plans, and oversee regulatory documents.</li>
<li>Adverse Event Reporting: Manage investigations and reporting of adverse events, lead root cause analysis, and maintain records.</li>
<li>Data Analysis: Analyze PMS data, collaborate on evaluations, and ensure alignment with the QMS.</li>
<li>Global Compliance: Monitor global PMS requirements, provide guidance, and support audits and submissions.</li>
</ul>
<h2 id="requirements">Requirements</h2>
<ul>
<li>Education: Bachelor&#39;s degree in life sciences, biomedical engineering, regulatory affairs, or related field. Certification in regulatory affairs or project management is a plus.</li>
<li>Experience: 7-10 years in regulatory affairs for IVD or medical devices, with experience in NPD and global submissions. Proven track record in regulatory submissions and interactions with authorities.</li>
<li>Skills: Understanding of global regulatory frameworks, project management, analytical and problem-solving skills, strong communication, collaborative mindset, proficiency in PMS tools, and knowledge of risk management principles.</li>
</ul>
<h2 id="benefits">Benefits</h2>
<ul>
<li>Flexible working hours, 50% remote work possible </li>
<li>30 days of holiday per year</li>
<li>13,5 salaries a year</li>
<li>Modern office and inspiring working environment</li>
<li>Subsidized meals in the neighborhood of our office (Stadtküche)</li>
<li>Public transport ticket (100% subsidized) or free parking space</li>
<li>Bike leasing</li>
<li>Subsidy fitness first gym</li>
<li>Employee Assistance Program to support your health, mental and emotional well-being</li>
<li>Comprehensive company pension scheme</li>
<li>Joint company events and activities</li>
</ul>
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

Senior Regulatory Affairs Project & PMS Manager (m/f/d) - Clinical Business

Customer Care and Sales Administration Specialist with French and German

Finance Manager EMEA (m/f/d)

HR Business Partner (m/f/d)

EVIDENT Europe GmbH logo

Google {privacyLink} and {termsLink} apply.

Benefits

Media

We don't have any open positions at the moment

No available jobs

Offices

Open positions

Values

Videos

Do you have a question?

Spontaneous Application

We’ll send a link to this job to your email.

No time? Just apply later

We are reviewing your account. Once our managers approve it, candidates will be able to apply for this job.

Changes are not visible until you publish your job.

This is a preview of your job ad.

Interested?

The job {jobTitle} was archived or the deadline has passed.

This job is no longer available

Recruiting Team

Our other open positions

We no longer accept spontaneous applications

Are you a talented professional seeking your next career adventure? At {companyName}, we appreciate proactive individuals who can bring a fresh perspective to our team.

While we may not have an immediate job opening that precisely matches your needs, your distinctive experiences and talents might be an excellent fit for us in the future.

To submit your spontaneous application, please use the application form on the right to upload your CV and cover letter. Ensure that you mention your desired position in the cover letter.

Rest assured, our dedicated recruiting team will reach out to you once they identify a role that aligns perfectly with your skills and aspirations.

How to apply

Looking for a job at {companyName}? JOIN works directly with {companyName} to bring you all their open positions. Apply now with JOIN.com.

Jobs at {companyName}. Browse all open positions and become part of our team! Open positions: {jobsCount}

Jobs at {companyName}. Browse our open jobs and join us! We currently have {jobsCount} available jobs. Step up your career and apply today!

Jobs at {companyName}. Browse all our open positions and become part of our team! We have currently {jobsCount} jobs available. Apply today to join us!

Jobs at {companyName}. Browse all open positions and become part of our team! We are currently looking for {jobsCount} additions to our company. Apply today!

Jobs at {companyName}. Browse all open positions and become part of our growing team! We are currently looking for {jobsCount} additions to our company. Apply today!

Jobs at {companyName}. Browse all our open positions and become part of our growing team! We are currently looking for {jobsCount} additions to our company. Apply today!

Browse all our open positions and become part of our team! We are looking for {jobsCount} additions to our company. Take the next step in your career and apply today!

No suitable positions available at {companyName}? Don't wait! Submit a spontaneous job application today and unlock your career possibilities tomorrow.

Our other open positionsView all open positions

Customer Care and Sales Administration Specialist with French and German

Finance Manager EMEA (m/f/d)

HR Business Partner (m/f/d)

HR Business Partner (m/f/d)

Our other open positions
View all open positions