Regulatory Affairs – Germany

Resourcing Life Science; Deutschland; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Resourcing Life Science is seeking a regulatory affairs professional to manage global regulatory submissions and EU MDR compliance across markets. You will collaborate with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.

The role involves preparing and filing regulatory submissions, maintaining technical documentation, and supporting inspections and audits by global authorities. Fluent English is required for this position.

Qualifikationen

• Minimum 5 years of regulatory experience.
• Fluent English required.

Aufgaben

• Establish and manage regulatory submission timelines across global markets.
• Prepare and file global medical device applications and amendments.
• Engage with regulatory authorities and distribution partners to support product registrations.
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead EU regulatory initiatives.
• Conduct global regulatory impact assessments for 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 directives to ensure ongoing global compliance.
• Review and approve product labeling to ensure compliance with global regulatory requirements.
• Support and participate in inspections and audits conducted by global regulatory authorities.

Kenntnisse

Regulatory affairs

EU MDR

Regulatory submissions

Documentation management

English fluency

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