Regulatory Affairs Officer

INDIBA Group

. Participate in regulatory processes to obtain market clearances through health ministries and regulatory authorities .

Posted 9/30/2026full-timeSant Quirze del Vallès • SpainMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices and pharmaceuticals, ensuring compliance with international regulations such as ISO 13485 and the Medical Device Regulation (MDR) 2017/745. Proficient in preparing technical files and coordinating with stakeholders to meet quality standards and deadlines.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device Legislation KnowledgeISO 13485 ComplianceFluency in Spanish and EnglishQuality Management Systems Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceTechnical File PreparationMedical Device Regulation (MDR) 2017/745Quality Management SystemsUS FDA RegulationsMDSAP KnowledgeClaim Submission SupportProduct CE MarkingAnnex XVI Device KnowledgeRegulatory Approval Maintenance

Soft Skills

CollaborationCommunicationWorkflow CoordinationStakeholder EngagementAttention to Detail

Industry Keywords

Health SciencesBioengineeringPharmaceuticalsMedical DevicesRegulatory AuthoritiesEuropean UnionJapanAustraliaSouth KoreaCosmetic Products

About the role

Key responsibilities & impact

Participate in regulatory processes to obtain market clearances through health ministries and regulatory authorities
Support new claim submissions and product CE marking activities
Ensure regulatory compliance in regions where medical devices are marketed, including the European Union, the United States, Japan, Australia and South Korea
Support preparation and submission of medical device technical files and cosmetic product dossiers
Ensure regulatory deliverables meet required quality standards and deadlines
Coordinate workflows with colleagues and internal and external stakeholders
Stay up to date with relevant legislation and regulatory requirements
Support maintenance and development of Quality Management Systems, including ISO 13485 and MDSAP
Obtain, update and maintain regulatory approvals worldwide for medical devices and cosmetic products

Requirements

What you’ll need

A degree in health sciences, bioengineering, chemistry, biology, pharmacy or a related field
At least three years of experience in regulatory affairs within a medical device or pharmaceutical company, or a regulatory consultancy
In-depth knowledge of medical device legislation, particularly the Medical Device Regulation (MDR) 2017/745 and ISO 13485
Experience with devices covered by Annex XVI, relating to products without an intended medical purpose, will be an advantage
Knowledge of US FDA regulations and other MDSAP countries will be an advantage
Fluency in Spanish and English, both written and spoken
Fluency in an additional language will be an advantage

Benefits

Comp & perks

A full-time, permanent contract
A hybrid working model
An attractive remuneration package
Fringe benefits
A flexible, international working environment