Regulatory Affairs Specialist

VITROLIFE A/S; Valencia; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A global medical device company is seeking a Regulatory Affairs Specialist in Valencia to lead regulatory initiatives in product development and compliance. Candidates should have 2–5 years' experience in regulatory affairs, strong knowledge of EU regulations, and fluency in Spanish and English. This role involves collaboration with various departments to ensure adherence to regulatory standards. Competitive salary and benefits offered.

Servicios

Competitive salary

Support for ongoing professional development

Collaborative work environment

Formación

• 2–5 years of experience in regulatory affairs, preferably within the IVD or medical device industry.
• Strong knowledge of EU IVDR and/or ISO 15189 requirements.
• Fluent in both Spanish and English.

Responsabilidades

• Ensure ongoing compliance with regulations across Europe, the Middle East and Africa.
• Prepare and compile regulatory dossiers for IVD products and lab-developed tests.
• Work closely with R&D, Quality Assurance, Clinical Affairs, and Marketing.
• Monitor changes in global regulatory landscapes.
• Maintain regulatory files and records.

Conocimientos

Analytical skills

Team collaboration

Knowledge of EU IVDR

Adaptability

Attention to detail

Educación

Bachelor’s or Master’s degree in biology, chemistry, physics, or equivalent

Descripción del empleo

Apply for this job

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby.

Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment.

About the Role

As Regulatory Affairs Specialist, you will lead regulatory initiatives across product development, manufacturing, and distribution. You’ll liaise with regulatory authorities, support global sales growth through new product registrations and ongoing regulatory maintenance.

You’ll thrive in a collaborative environment alongside highly skilled and dedicated colleagues. Whether managing regulatory affairs projects or diving deep into country-specific regulatory standards, your adaptability and interpersonal skills will be key to success.

This role focuses on ensuring our products and genetic services meet global regulatory requirements throughout the product lifecycle – from development through commercialization – in close collaboration with our post‑market surveillance team.

Key Responsibilities

• Compliance Monitoring: Ensure ongoing compliance with regulations across Europe, the Middle East and Africa (e.g., EU IVDR 2017/746, LDT frameworks, DHA regulations).
• Regulatory Submissions: Prepare and compile regulatory dossiers (e.g., CE marking under IVDR, local registrations, etc.) for new and existing IVD products and lab‑developed tests (LDTs).
• Cross‑functional Collaboration: Work closely with R&D, Quality Assurance, Clinical Affairs, and Marketing to support regulatory strategies and product development.
• Regulatory Intelligence: Monitor changes in global regulatory landscapes and assess their impact on company products and processes.
• Documentation Management: Maintain regulatory files and records in accordance with internal procedures and regulatory requirements.

Who are you?

• Hold a Bachelor’s or Master’s degree in biology, chemistry, physics, or equivalent or experience in regulatory affairs for ART.
• Bring 2–5 years of experience in regulatory affairs, preferably within the IVD or medical device industry.
• Possess strong knowledge of EU IVDR and/or ISO 15189 requirements.
• Systematic and analytical, yet proactive and pragmatic in finding solutions within a dynamic environment.
• Detail‑oriented, decisive, and a true team player, who builds strong relationships.
• Curious and passionate about regulatory affairs with a technical interest in genetic services.
• Fluent in both Spanish and English.

Preferred Skills

• RAC (Regulatory Affairs Certification) is a plus.
• Experience with software‑based IVDs or IEC 62304 is highly desirable.

Why Join Us

• Be part of a mission‑driven team improving patient outcomes through innovative diagnostics.
• Work in a collaborative, fast‑paced environment with opportunities for growth.
• Enjoy a competitive salary, benefits, and support for ongoing professional development.

Apply today

We’re eager to fill this position and will conduct interviews on a rolling basis until the right candidate is found. We look forward to hearing from you!

Vitrolife Group is an equal opportunity employer. We welcome and encourage applications from people with disabilities.

We are currently approximately 1,100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group’s products and services are available in more than 125 countries, through our own presence in more than 25 countries and a network of distributors. The Vitrolife AB (publ) share is listed on the Nasdaq Stockholm.

Department: Quality & Regulatory
Locations: Valencia
Remote status: Hybrid
Employment type: Full‑time
Company: Vitrolife Group