Senior Regulatory Affairs Engineer (Pre-Market)

AbleCloset; Barcelona; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Regulatory Affairs Engineer to ensure compliance with regulatory standards in the medical device sector. This role, based in Barcelona, involves preparing technical documentation, guiding teams on regulatory legislation, and collaborating with R&D to support product development. The ideal candidate will have a minimum of 5 years' experience in Regulatory Affairs, particularly with active medical devices, and possess strong analytical and communication skills. Join a dynamic international environment that values engagement and offers growth opportunities in a collaborative culture.

Servicios

Medical Insurance

Dental Insurance

Dynamic International Environment

Growth Opportunities

Formación

• 5+ years in Regulatory Affairs for active medical devices.
• Knowledge of IEC standards and Medical Device Regulation.
• Strong attention to detail in documentation.

Responsabilidades

• Prepare technical documentation for global regulatory filings.
• Collaborate with teams to implement new regulatory requirements.
• Review documents for regulatory impact and compliance.

Conocimientos

Regulatory Affairs

Medical Device Regulations

IEC 60601

IEC 62304

Documentation Review

Communication Skills

Analytical Thinking

Time Management

Cybersecurity

AI Knowledge

Descripción del empleo

Job Details : Senior Regulatory Affairs Engineer (Pre-Market) Full details of the job.

Vacancy Name : Senior Regulatory Affairs Engineer (Pre-Market)

Vacancy No : VN179

Employment Type : Full-Time

The Role

Sinclair is seeking a Pre-Market Regulatory Affairs Engineer at its offices in Esplugues del Llobregat (Barcelona). The engineer will work within the Corporate Regulatory Affairs Team to ensure compliance with regulatory requirements for new product development and design changes to existing devices.

Reporting to the Team Leader, Registration and Regulatory Affairs Engineer, the role involves ensuring design and development processes meet regulatory standards and supporting documentation. The engineer will collaborate with R&D and other departments to ensure testing certifications and standards compliance, maintaining the integrity of technical documentation for country-specific registrations.

The position contributes to regulatory deliverables from R&D projects, providing solutions aligned with the regulatory landscape and ensuring compliance with UK, European, USA, and international legislation. Responsibilities include preparing dossiers and managing submissions to regulatory agencies worldwide.

Your Skills & Experience – Do You Have What it Takes?

• Minimum 5 years experience in Regulatory Affairs (Pre-Market) within the Medical Device industry, specifically with active medical devices.
• Knowledge of active devices and standards such as IEC 60601 / IEC 62304.
• Experience with the Medical Device Regulation.
• Understanding of other relevant regulations (EU, US, Canada).
• Attention to detail in documentation review and preparation.
• Organized, target-oriented, flexible, with good time management.
• Strong communication skills, fluency in English.
• Preferred experience with cybersecurity or AI.

A bit about you – do you fit this description?

• Personal responsibility and autonomy.
• Effective communication and influence skills.
• Analytical and critical thinking.
• Time management, organization, and planning skills.
• Attention to quality and accuracy.
• Achievement-oriented, adaptable, and open to change.
• Willingness to learn, integrity, and professional ethics.
• Ability to work across disciplines collaboratively.

If you meet these requirements, we encourage you to apply. Please note, applications may close early if we receive high volume.

By applying, you consent to the use of your personal data in automated decision processes related to the job requirements.

For questions, please email us.

Note: Sinclair does not accept unsolicited CVs from recruitment agencies; any received will be considered property of Sinclair.

Key Responsibilities

• Provide guidance on regulatory legislation and standards, especially in EU, US, and Canada.
• Prepare technical documentation and submission packages for global regulatory filings.
• Maintain regulatory information systems and documentation files.
• Collaborate with global teams to understand and implement new requirements.
• Ensure compliance with global and company policies.
• Review documents and product changes for regulatory impact.
• Advise and guide other personnel on regulatory matters.
• Review and approve product artworks and marketing materials.
• Participate in training to develop regulatory expertise.
• Assist with vigilance, risk management, inspections, and audits.
• Support the creation and implementation of regulatory processes and training.
• Lead registration processes in markets of commercialization.
• Prepare documentation for product registration with health authorities.
• Handle administrative procedures for document legalization.
• Coordinate signatures for quality and release certificates.
• Deputise for the manager as needed.

We offer a competitive salary, benefits including medical and dental insurance, a dynamic international environment, and opportunities for growth within a culture that values engagement, development, and cross-functional collaboration.