Regulatory Affairs Senior Specialist EMEA M/F

Jordan martorell s.l.; Barcelona; Híbrido; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Regulatory Affairs Specialist to lead technical documentation and ensure compliance with EU MDR and FDA regulations. This role involves preparing essential reports, maintaining quality management systems, and supporting product development in a collaborative global environment. The company values diversity and offers a supportive culture that empowers employees to thrive. Join a dynamic team dedicated to innovation in the medical device sector, where your expertise will contribute to improving patient care and outcomes. This opportunity provides career growth in a field that is both challenging and rewarding.

Servicios

Competitive compensation package

Permanent contract

Partially remote work option

Private life insurance

Health insurance

Dental insurance

Formación

• 5 years’ experience in regulatory compliance and clinical affairs.
• Expertise in ISO standards and EU MDR requirements.

Responsabilidades

• Prepare technical documentation including biocompatibility and clinical reports.
• Support QMS maintenance and assist in regulatory submissions.

Conocimientos

Regulatory Compliance

Clinical Affairs

ISO 10993

ISO 14155

ISO 13485

EU MDR Implementation

FDA 21 CFR 820

Communications Skills

Organizational Skills

Fluency in English

Educación

University degree in Science

Descripción del empleo

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you’ll consider being a part of it!

About the role:

Lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. Assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.

What you’ll be doing:

1. Prepare CERs for the Technical Documentations
2. Prepare post-market surveillance reports
3. Prepare biocompatibility reports
4. Maintain and prepare Technical Documentations according to EU MDR requirements
5. Review new regulatory requirements and implement them accordingly
6. Support QMS maintenance including alignment with QMS of ZimVie
7. Support R&D in the development of new products
8. Prepare and submit 510(k)
9. Participate in External and Internal audits

What you’ll need:

1. University degree in a Science related subject (e.g., Biology, Biotechnology, Pharmacy, etc.)
2. 5 years’ experience in a similar position
3. SME in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, FDA 21 CFR 820 and submission of 510(k)
4. Communications and organizational skills
5. Fluent in English; other European languages are a plus
6. Initiative, flexibility, and team player
7. Possibility to travel to Spain, Italy, and Germany

What we offer:

Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.

ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:

1. Competitive compensation package
2. Permanent contract
3. Partially remote work option available
4. Private life, health, and dental insurance

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc., are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age, or sexual identity.

ZimVie generally does not sponsor applicant work visas for this position.