20 meilleures offres (regulatory affairs, mechelen, vlg) (à pourvoir)

Regulatory Affairs Specialist
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- De 40 000 € à 50 000 € par an
- Microsoft Powerpoint
- Microsoft Word
- Espagnol
il y a 13 jours
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Tether Operations Limited —Bruxelles
- Temps plein
- Télétravail
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- Temps plein
- Doctorat
- Master
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Medical Information & PV Officer
Chiesi Farmaceutici —Zaventem
- Bureau
- Bachelier
- Compétences en communication
Quality Specialist
Hologic —Zaventem
- De 50 000 € à 70 000 € par an
- Systèmes PGI
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Regulatory Affairs Manager
Nipro —Malines
- Expérience en gestion d'équipe
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CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab —Berchem
- Temps plein
- Doctorat
- Vente
- Anglais
il y a 4 jours
Medical Advisor Cardiorenal - Benelux
CSL Behring —Malines
- Temps plein
- Master
- Leadership
- Compétences en communication
Clinical Affairs Officer
Covartim —Bruxelles
- De 2 800 € à 5 500 € par mois
- Anglais
- Bureau
Regulatory Affairs Manager
Nipro Europe Group Companies —Malines
- Expérience en gestion d'équipe
- Bureau
- Gestion d'équipe
Medical Science Liaison Psoriasis Belux
LEO Pharma A/S —Bruxelles
- Vente
- Gestion de projet
il y a 4 jours
Head of Regulatory Affairs
Allianz —Bruxelles
- Temps plein
- Doctorat
- Anglais
- Finance
il y a 4 jours
Regulatory & Public Affairs Counsel
Eneco —Malines
- Travail hybride
- Anglais
- Bureau
- En présentiel
Clinical Project Manager (IVD experience required)
Biocartis —Malines
- Temps plein
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab Inc. —Berchem
- Temps plein
- Doctorat
- Vente
- Anglais
il y a 4 jours
Auditor QA Pharmaco Vigilance | Brussel | 4 days/week
Plasma Industries Belgium —Bruxelles
- Microsoft Excel
- Microsoft Access
- Bachelier

Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : regulatory affairs (mechelen, vlg)

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Regulatory Affairs Specialist

Hologic -
Zaventem

Soumettre votre candidature

Détails de l'emploi

De 40 000 € à 50 000 € par an
Il y a 13 jours

Qualifications

Microsoft Powerpoint
Microsoft Word
Espagnol
Microsoft Excel
Microsoft Outlook
Esprit d'analyse
SharePoint
Portugais
IT
Italien
Compétences en communication

Description complète du poste

Regulatory Affairs Specialist, Southern Europe

Location: Madrid, Spain OR Zaventem, Belgium

Hologic is a leading developer, manufacturer, and supplier of diagnostic products, medical imaging systems, and surgical products, with a strong emphasis on serving the healthcare needs of women. Our mission is to improve and save lives through early detection of cervical and breast cancer, improved diagnosis, and less invasive treatments.

We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs EMEA team, taking ownership of regulatory activities across Southern Europe.

What To Expect:

Manage and maintain regulatory notifications and registrations for medical devices across all Hologic product lines in Southern Europe including in Greece, Spain, Portugal, Italy, and Malta.
Serve as the primary contact with Competent Authorities in assigned countries, supporting communications as needed.
Review scientific and clinical literature to support product registrations and ongoing regulatory compliance.
Review and approve documentation, labelling, and promotional materials to ensure regulatory compliance.
Maintain accurate regulatory records and databases, in-country registration requirements, and product documentation files.
Monitor current and upcoming regulations, standards, and guidelines impacting the business, and communicate key updates to the RA team.
Support regulatory activities for new product launches and introductions, including participation in cross-functional core team meetings.
Respond to regulatory inquiries from distributors, customers, sales, marketing, customer service, and other internal stakeholders.
Provide regulatory support for tenders, ensuring complete and timely responses to meet business deadlines.
Represent the Regulatory Affairs function in internal and external meetings, including industry association meetings, and take ownership of follow-up actions.
Provide broader regional regulatory support, maintain shared platforms such as network drives and SharePoint, and report progress regularly to the RA EMEA team.

What We Expect:

5+ years of professional experience in a Regulatory role within the life sciences industry, ideally within the medtech sector and product registration.
Fluent English and Spanish are essential. Italian and Portuguese are an asset.
Strong analytical skills and a high level of attention to detail.
Strong problem-solving skills, with the ability to propose pragmatic, compliant solutions.
Proficiency in IT tools such as Outlook, Word, Excel, and PowerPoint.
Self-motivated, proactive, curious, and eager to learn.
Well-organised and able to work independently while collaborating effectively with cross-functional and international teams.
Strong oral and written communication skills, including the ability to communicate complex regulatory concepts clearly to non-regulatory stakeholders.
Willingness to travel occasionally (approximately 10%).

So Why Join Hologic?

We are committed to making Hologic a place where top talent comes to grow. To support your success, we provide:

Continued development opportunities throughout your career, including exposure to regional and cross-functional initiatives.
The chance to directly impact women's health and patient outcomes across Southern Europe and beyond.
If you have the right skills, experience, and mindset and you are excited by the challenge of driving regulatory excellence across Southern Europe — apply today. We look forward to hearing from you.

Salary: €40,000 – €50,000 gross per year

The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : regulatory affairs (mechelen, vlg)

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