Regulatory Affairs – Germany

Resourcing Life Science; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading Life Sciences company in Germany seeks a Regulatory Affairs expert with at least 5 years of experience. The role involves managing regulatory submissions across global markets, ensuring compliance with international regulations, and collaborating with various teams throughout the product lifecycle.

Qualifikationen

• Minimum 5 years of experience in Regulatory Affairs or related field.
• Fluent in English.

Aufgaben

• Manage regulatory submission timelines for global markets.
• Prepare and file medical device applications and amendments.
• Collaborate with cross-functional teams to integrate regulatory requirements.

Kenntnisse

Regulatory Compliance

Documentation Management

Product Lifecycle Management

Communication

Team Collaboration

Jobbeschreibung

What to Expect

• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partnersto support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
• Review and approve product labelingto ensure compliance with global regulatory requirements.
• Support and participate in inspections and auditsconducted by global regulatory authorities.

Requirements

• Minimum 5 years of Experience
• Fluent English

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or [e-mail]

Tagged as: Regulatory Affair