Pre Market Quality and Regulatory Specialist (m/f/d)

Dedalus HealthCare GmbH; Bonn; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A health technology company in Bonn seeks a Pre-Market Quality and Regulatory Specialist. The role involves ensuring regulatory compliance for medical devices, coordinating submissions, and performing audits. Ideal candidates have a related degree and experience in a regulated industry. This position offers a permanent contract, flexible hours, and opportunities for professional growth in an innovative environment.

Leistungen

Permanent contract

Flexible hours and work models

Home office options

Company-provided mobile phone

Free parking and drinks

Company pension

Qualifikationen

• 3+ years experience in regulated industry, preferably medical devices or pharmaceuticals.
• Ability to interpret regulations for a general audience.
• Familiar with ISO 13485, ISO 14971, IEC 62304.

Aufgaben

• Ensure process adherence for pre-market procedures.
• Coordinate regulatory and CE submissions.
• Perform internal audits and defend pre-market activities.

Kenntnisse

Regulatory affairs expertise

Project management skills

Attention to detail

Bilingual in German and English

Ausbildung

University Degree in Engineering, Computer Science, or Science

Tools

Microsoft Office

Enterprise software applications

Jobbeschreibung

Pre Market Quality and Regulatory Specialist (m/f/d)

Pre Market Quality and Regulatory Specialist (m/f/d)

Apply locations: DEU - Bonn | Time type: Full time | Posted on: Posted 4 Days Ago | Job requisition id: JR107087

Do you want a job with a purpose?

And do you want to make healthcare safer, better and more reliable?

Join our Team!

We are looking for a Pre-Market Quality and Regulatory Specialist (m/f/d) based in Bonn (Hybrid).

Your tasks:

1. Ensuring process adherence for pre-market procedures.
2. Completeness of design history files and regulatory submissions.
3. Regulatory and process conformance in development and maintenance projects as part of cross-functional teams.
4. Creation and maintenance of key regulatory deliverables.
5. Coordination of regulatory and CE submissions with regional QARA organizations.
6. Ensuring compliance with medical device risk analysis processes, acting as risk moderator.
7. Facilitating regulatory compliance in design control processes to pass inspections.
8. Performing internal audits and defending pre-market activities during external inspections.
9. Acting as a QARA ambassador on product teams.

You bring along:

1. University Degree (Engineering, Computer Science, or Science) or equivalent.
2. At least 3 years of experience in a regulated industry, preferably medical devices or pharmaceuticals, in project management, quality management, or regulatory affairs.
3. Ability to work independently towards deadlines, with strong attention to detail, and interpret regulations for a general audience.
4. Subject matter expertise in regulatory affairs, familiar with standards like ISO 13485, ISO 14971, IEC 62304, IEC 62366, MDR, IVDR.
5. Awareness of product safety and security standards, including ISO 27001, GDPR, and others relevant by region (e.g., FDA, ANVISA).
6. Proficiency in Microsoft Office and enterprise software applications.
7. Language skills: German and English (upper intermediate or better).

What we offer:

1. Permanent contract with attractive salary and long-term prospects.
2. Flexible hours and work models for work-life balance.
3. Home office options with TicketPlusCity card.
4. Flexitime and innovative work environment.
5. Training and development opportunities.
6. Company-provided mobile phone (Android/iOS) for work and private use.
7. Free parking, drinks, weekly fruit basket.
8. Company pension, working time accounts, group accident insurance, health insurance for trips.
9. Team activities and social events.

Join our innovative team and shape the future!

#teamdedalus #together4success #dedalusgroup

We look forward to your online application!

Severely disabled applicants will be given special consideration if equally qualified.

Dedalus HealthCare GmbH

Human Resources

Monaiser Straße 11a, 54294 Trier

https://www.dedalusgroup.de

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We are Dedalus, come join us

Dedalus is committed to providing an engaging, rewarding work environment that reflects the passion of our employees in delivering better healthcare.

Our culture encourages learning, innovation, and collaboration to improve clinical processes and outcomes for millions worldwide.

Our diverse team of over 7,600 people across more than 40 countries works together to drive healthcare innovation. We are proud of our team of Dedalus employees.

Our Diversity & Inclusion Commitment emphasizes respect, inclusion, and success for all colleagues and communities. We aim to be authentic, realistic, and ambitious in fostering an inclusive workplace.

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