Regulatory Affairs Specialist

Hologic, Inc.; Madrid; Presencial; EUR 40.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pension plan

Insurance coverage

Career development

Descripción de la vacante

Hologic, Inc. is seeking a Regulatory Affairs Specialist to join our EMEA team, taking ownership of regulatory activities across Southern Europe.

You will liaise with Competent Authorities, review clinical and regulatory documentation, and ensure ongoing compliance across Greece, Spain, Portugal, Italy and Malta. Ideal candidates have 5+ years in regulatory roles within life sciences, fluent English and Spanish, and strong analytical and communication skills.

Formación

• 5+ years of professional experience in regulatory roles within life sciences, preferably medtech.
• Fluent English and Spanish are essential; Italian/Portuguese are assets.
• Strong analytical skills and high attention to detail.
• Strong problem-solving abilities and pragmatic regulatory solutions.
• Proficiency with Outlook, Word, Excel and PowerPoint.
• Self-motivated, proactive, curious and eager to learn.
• Well-organised and able to work independently with cross-functional teams.
• Strong oral and written communication to explain regulatory concepts clearly.
• Willingness to travel approximately 10%.

Responsabilidades

• Manage and maintain regulatory notifications and registrations for medical devices across Southern Europe (Greece, Spain, Portugal, Italy, Malta).
• Serve as the primary contact with Competent Authorities in assigned countries.
• Review scientific/clinical literature to support registrations and ongoing regulatory compliance.
• Review and approve documentation, labelling and promotional materials for regulatory compliance.
• Maintain regulatory records and in-country documentation files; ensure up-to-date registrations.
• Monitor regulations, standards and guidelines; communicate updates to RA team.
• Support regulatory activities for new product launches and cross-functional meetings.
• Respond to regulatory inquiries from distributors, customers, sales, marketing and service teams.

Conocimientos

Fluent English

Fluent Spanish

Analytical thinking

Problem solving

Self-motivated

Well-organised

Effective communication

Herramientas

Outlook

Word

Excel

PowerPoint

Descripción del empleo

Regulatory Affairs Specialist, Southern Europe

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.