Staffing and Recruiting

gloor&lang AG

1-10

Switzerland

## Medical Devices class III - MDR – combination devices

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Join the Headquarter of an impressive independent Medical Devices company in Switzerland! Innovative implants registered as class II-III medical devices are developed, manufactured and distributed on site. Some of the exciting products are drug-device combination products!  __Your Challenges__ * Implement the new MDR in the regulatory processes with MDD considering for class II – III medical devices
* Prepare international submissions
* Develop and write clear arguments and explanations for new product certifications and license renewals
* Monitor and set timelines for certification and/or license variations and renewal approvals
* Provide input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned
* Provide regulatory intelligence information to the organization

__Your Experience__ * BSc/MSc degree in scientific discipline biology, chemistry, engineering or equivalent
* > 3 years of experience in general regulatory affairs
* Experience with international medical device (class II & III) regulatory approvals and submissions
* In depth knowledge on the new MDR and/or international regulations
* Strong project management

You are a collaborative, empathic and solution-oriented individual. Excellent command of spoken and written English is necessary, German knowledge is an asset for internal communication. You provide adequate attention and support to internal departments. Your autonomy, your integrity, and your initiative are of high value.

Employee

<h2 id="medical-devices-class-iii---mdr--combination-devices">Medical Devices class III - MDR – combination devices</h2>
--- |
Join the Headquarter of an impressive independent Medical Devices company in Switzerland! Innovative implants registered as class II-III medical devices are developed, manufactured and distributed on site. Some of the exciting products are drug-device combination products! Your Challenges * Implement the new MDR in the regulatory processes with MDD considering for class II – III medical devices
<ul>
<li>Prepare international submissions</li>
<li>Develop and write clear arguments and explanations for new product certifications and license renewals</li>
<li>Monitor and set timelines for certification and/or license variations and renewal approvals</li>
<li>Provide input to project teams during the development of regulatory plans &amp; filing strategy to ensure acceptable labelling in markets assigned</li>
<li>Provide regulatory intelligence information to the organization</li>
</ul>
Your Experience * BSc/MSc degree in scientific discipline biology, chemistry, engineering or equivalent
<ul>
<li><blockquote>
3 years of experience in general regulatory affairs
</blockquote>
</li>
<li>Experience with international medical device (class II &amp; III) regulatory approvals and submissions</li>
<li>In depth knowledge on the new MDR and/or international regulations</li>
<li>Strong project management</li>
</ul>
You are a collaborative, empathic and solution-oriented individual. Excellent command of spoken and written English is necessary, German knowledge is an asset for internal communication. You provide adequate attention and support to internal departments. Your autonomy, your integrity, and your initiative are of high value.

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