Regulatory Affairs – Denmark

Resourcing Life Science; Denmark; On-site; DKK 600,000 - 900,000; Full time

Job summary

A leading life science recruitment agency in Denmark is seeking a regulatory affairs specialist with a minimum of 5 years of experience in managing global regulatory submissions for medical devices. The role involves preparing applications and engaging with authorities to ensure timely market access. Strong knowledge of EU regulations is essential. Fluency in English is required. This position offers an opportunity to work with cross-functional teams while ensuring compliance throughout the product lifecycle.

Qualifications

• Minimum 5 years of experience in regulatory affairs or related field.
• Strong knowledge of global regulatory requirements for medical devices.
• Experience with EU MDR and global submissions.

Responsibilities

• Establish and manage regulatory submission timelines.
• Prepare and file global medical device applications.
• Engage with regulatory authorities for 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 regulatory updates.
• Act as 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.

Skills

Regulatory submission management

Fluent English

Documentation management

EU MDR knowledge

Job description

What to Expect

• Establish and manage regulatory submission timelines for 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 partners to 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 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.

Responsibilities

• 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 email [e-mail]