Senior Regulatory Affairs Associate - Medical Device

Randstad España; Barcelona; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Randstad España is looking for a Senior Regulatory Affairs Associate to lead regulatory activities related to medical devices. This role involves ensuring compliance with various regulations, leading document preparations, and coordinating audits. Candidates should possess a related degree and substantial experience in regulatory affairs, particularly within the medical device sector.

Formación

• 4–6 years of experience in regulatory affairs for medical devices.
• Proven experience with IVDR and/or FDA pathways.
• Excellent verbal and written communication in English.

Responsabilidades

• Lead regulatory activities for medical devices including compliance and documentation.
• Communication with regulatory authorities and notified bodies.
• Coordinate audits and inspections.

Conocimientos

Communication

Compliance

Regulatory Strategy

Educación

Bachelor’s degree in Life Sciences, Pharmacy, or related field

Descripción del empleo

Senior Regulatory Affairs Associate - Medical Device

Senior Regulatory Affairs Associate - Medical Device

To lead and oversee all regulatory activities related to the development, approval, and commercialization of the company’s in vitro medical devices. The Regulatory Affairs Manager ensures implementation of Quality Management System, compliance with applicable regulations (such as IVDR, ISO 13485, and FDA guidance), manages regulatory submissions and audits, and contributes to the overall strategy to bring innovative products to market efficiently and compliantly.

Responsabilities :

• Define and implement regulatory strategies for new and existing products.
• Ensure compliance with applicable regulations (IVDR, MDR, ISO 13485, FDA, etc.).
• Prepare and maintain regulatory documentation and technical files.
• Accountable for the implementation of the Quality Management System.
• Acts as a Person Responsible for Regulatory Compliance.
• Acts as a Vigilance Manager.
• Lead communication with regulatory authorities and notified bodies.
• Monitor regulatory changes and ensure timely adaptation of internal processes.
• Performs internal reviews to confirm compliance with QMS and regulatory standards
• Support internal teams (R&D, Clinical) to ensure compliance across the product lifecycle.
• Coordinate and provide guidance during audits, inspections, and certification processes.
• Train and mentor team members on regulatory best practices.

Requirements :

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical, Engineering, or a related field.
• 4–6 years of experience in regulatory affairs for medical devices or diagnostics.
• Proven experience with IVDR and / or FDA regulatory pathways.
• Excellent verbal and written communication in English.

WeAreRSC

Randstad promotes equal employment opportunities through diverse and inclusive teams. That is why, in our processes, we ensure the inclusion of all individuals, regardless of their personal circumstances, gender, sexual orientation, ethnicity, culture, age, religion, or disability.

NetZeroCommitment

Randstad is committed to reducing its environmental impact to create a better environment for everyone. Our commitment to the Science Based Targets (SBTi) initiative, whose objectives are science-based, drives Randstad's ambition to achieve Net Zero by 2050.

Seniority level

Seniority level

Associate

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Medical Equipment Manufacturing

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