Regulatory Affairs Manager Equipment (all genders)

Ivoclar EMEA; Naturno; On-site; EUR 40,000 - 48,000; Full time

Benefits offered by this job

Global company

Culture of innovation

Learning and development tailored to成长

Job summary

Ivoclar EMEA is seeking a Regulatory Affairs professional to develop regulatory strategies for electrical devices, coordinate international product registrations, and manage documentation throughout the product lifecycle.

You will work with Product Development, Sales and Marketing to implement regulatory plans, monitor changes, and support CAPA and NC processes. German and English language skills are essential for collaboration with international authorities.

Qualifications

• Regulatory affairs experience for electrical and medical devices preferred.
• In-depth knowledge of international approval requirements for electrical equipment and machinery.
• Structured, independent work style with cross-functional collaboration.

Responsibilities

• Develop regulatory strategies and coordinate international product registrations.
• Create and maintain national and international technical documentation.
• Collaborate with Product Development, Sales and Marketing to implement regulatory plans and manage deadlines.

Skills

Regulatory affairs

Electrical devices

Medical devices

Cross-functional collaboration

German language

English language

Education

Bachelor’s degree in engineering/medical tech

Job description

From Strategy to international Approval.

You develop regulatory strategies for our electrical devices, coordinate international product registrations, and manage them throughout the entire product lifecycle.

Your role

• You will support the implementation of regulatory requirements for our electrical equipment (ovens, milling machines, etc.) and share responsibility for creating and maintaining national and international technical documentation.
• Together with Product Development, Sales, and Marketing, you will develop the regulatory approval strategy, successfully implement it, and reliably manage deadlines and timelines.
• You will coordinate international product registrations—from new registrations and amendments to deregistration—in collaboration with subsidiaries, local partners, and regulatory authorities.
• You will use your expertise to support other departments with complaints, Non-Conformities (NCs), and Corrective and Preventive Actions (CAPA).
• You will monitor regulatory developments and assess the impact of changes on registrations.
• You will work as part of project teams.

Your profile

• Bachelor’s degree in medical technology, electrical engineering, electronics, mechanical engineering, or a comparable qualification
• Several years of experience in regulatory affairs for electrical devices and medical devices is a plus
• In-depth knowledge of regulatory requirements for electrical devices, machinery, and medical devices, as well as international approval requirements, is desired
• A structured, independent work style and a passion for cross-functional collaboration
• A pragmatic approach and a strong focus on finding solutions
• Excellent German and English language skills, additional languages are a plus

What We Offer

• A global, purpose-driven company with 3,700 employees.
• A culture of innovation and collaboration.
• Learning and development tailored to your growth.
• Attractive benefits.

For this full-time position (40 hours per week), the gross annual salary starts at 44,000 EUR and a variable bonus based on the company's earnings. Actual compensation will be determined based on professional qualifications, relevant work experience, and the skills required for the position. Salary classification is in accordance with the applicable working agreement for the rubber and plastics processing industry.