The Regulatory Affairs Senior Specialist plays an important role in ensuring compliance with regulatory requirements and maintaining the company’s strong reputation. The position supports global regulatory plans, manages product approvals, and ensures that products remain available and compliant across markets. This role helps protect the safety and trust behind the company’s work.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

Regulatory Affairs Senior Specialist – Job Responsibilities:

• Manage regulatory activities for a specific global portfolio of products/projects.
• Acquire and maintain marketing authorizations for the products and communicate local regulatory requirements.
• Act as a consultant on projects requiring RA advice.
• Understand all aspects and phases of role-based activities, including submission processes, ownership of regulatory systems, and stewardship of new/changing regulations.
• Respond to complex questions from regulatory authorities within strict timelines.
• Compile and submit regulatory documents according to requirements.
• Maintain and update existing regulatory authorizations.
• Review and approve labeling, SOPs, and AdProm materials for compliance.
• Handle and manipulate 3rd party providers and distributors.

Regulatory Affairs Senior Specialist – Job Qualifications:

• Minimum of 2 years of regulatory or equivalent experience within the medical devices industry.
• A degree in Pharmacy is a must 
• Proficient English skills.
• In-depth knowledge of regulations and scientific principles.
• Strong project management skills, with the ability to handle multiple projects.
• Excellent prioritization abilities.
• Exceptional interpersonal and communication skills.
• Technical proficiency in word processing, spreadsheets, databases, and online research.
• Identify compliance risks and effectively communicate concerns when needed.
• Effective listening abilities: Display active listening skills to comprehend and address the requirements and concerns of individuals involved.
• Ability to provide regular weekly updates on progress and explain the progress effectively.
• Ability to work effectively with other teams and adjust quickly to changing circumstances.
• Self-motivated with a high level of initiative: Proactively take ownership of tasks and drive projects forward.

Seize the opportunity to elevate your career as a Regulatory Affairs Senior Specialist in Medical Devices. Join a team that values precision, collaboration, and global impact – where your skills help shape high-quality, compliant products for markets around the world. Apply now and take the next step in your regulatory career.

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