Regulatory & Clinical Affairs Manager (m/f/d)

Location: Vorarlberg | Employment type: Full-time
from € 5,700.00 We offer an attractive, market-compliant salary significantly above the collective agreement

Tasks.

MDR Expert:

You plan, create, and maintain clinical and biological evaluations in accordance with Regulation (EU) 2017/745 (MDR) for dental restorative materials and the associated product portfolio in English.

Compliance Guarantor:

You ensure seamless adherence to all legal and regulatory requirements for medical devices (e.g., MDR, ISO 14971, ISO 14155).

Risk Analyst:

You professionally conduct and continuously maintain product-specific risk analyses.

Approval Strategist:

You develop future-proof and smart approval strategies for new, innovative medical devices.

Data Juggler:

You conduct thorough literature research, prepare precise analyses, and evaluate relevant clinical data.

Study Monitor:

You monitor clinical studies and act as a competent interface to our international study partners.

Post-Market Specialist:

You coordinate, document, and conduct post-market surveillance of all medical devices (PMS & PMCF).

Interface Professional:

You work closely and collaboratively with internal departments such as Product Management, R&D, Regulatory Affairs, and Quality Management.

Network Hub:

You maintain active contact with international professional circles and participate in relevant professional events.

Appreciation.

Fair & attractive remuneration.

Salary clearly above the collective agreement based on qualification. Accommodation is organized if needed and costs are covered accordingly.

Financial security.

Look forward to a 13th and 14th monthly salary (holiday & Christmas bonus) as well as a company pension scheme supported by us as an addition to your pension.

Strong team.

A collegiate and motivated team that sticks together awaits you. An often underestimated added value!

Pass it on.

Recommend a new colleague to us and secure an employee referral bonus of up to 1,000 EUR.

Regional advantages.

Benefit from discounted shopping opportunities at selected partner companies in the area.

Exclusive benefits for our team.

As an employee, you get access to the Corporate Benefits platform – Europe's leading provider of employee discounts.

Know-How.

Education & Experience:

You have a completed scientific degree (e.g., biology, chemistry, medicine, medical technology, material sciences) and at least 5 years of experience in Regulatory/Clinical Affairs for medical devices OR alternatively at least 10 years of relevant professional experience in this field.

Scientific Work:

You possess sound experience in scientific work and professional medical writing.

Communication Strength:

You excel through pronounced teamwork skills and clear, audience-appropriate communication at all levels.

Working Style:

You are characterized by initiative, responsibility, reliability, and a structured, organized, and resilient working style.

Mindset:

An analytical, solution-oriented mindset and a precise, quality-conscious, and methodical approach are self-evident for you.

Regulatory Confidence:

You confidently handle complex regulatory and scientific issues.

IT Skills:

Proficient use of MS Office (especially Word and Excel) is part of your daily toolkit.

Additional Qualifications:

Ideally, you have knowledge in audit, project, or process management; practical experience in risk management, usability engineering, or technical editing is a big plus.

Language Talent:

You possess very good German and English skills, both written and spoken, for the international arena.

Contact.

We are more than just a personnel service provider. Across national borders, we offer you security and orientation. At .mse, people and mutual appreciation are at the center of our actions.

The fastest way to join our team.

A short call or a WhatsApp message is enough!

Your contact person: Markus Schulze MSc

Our promise:

We will get back to you within 48 hours guaranteed!

Markus Schulze MSc

Personnel consultant

T: +41 58 726 26 21
Mobile/WhatsApp: +43 664 836 70 66
bewerbung@mse-personal.com

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