Regulatory Affairs Specialist

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

Ventajas ofrecidas por este puesto de trabajo

Pension

Insurances

Descripción de la vacante

Hologic is seeking a Regulatory Affairs Specialist to join our EMEA team, taking ownership of regulatory activities across Southern Europe including Spain, Greece, Portugal, Italy and Malta. The successful candidate will manage registrations, liaise with competent authorities, review documentation, monitor regulatory changes, and support product launches with cross‑functional teams.

Fluent English and Spanish are essential, travel up to 10% may be required, and a proactive, detail‑oriented

Formación

• 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%).

Responsabilidades

• Manage and maintain regulatory notifications and registrations for medical devices across Southern Europe.
• Serve as the primary contact with Competent Authorities in assigned countries.
• Review scientific and clinical literature to support product registrations and ongoing regulatory compliance.
• Review and approve documentation, labelling, and promotional materials for regulatory compliance.
• Maintain accurate regulatory records and databases and ensure in-country registration requirements.
• Monitor current and upcoming regulations, standards, and guidelines and communicate updates to RA team.
• Support regulatory activities for new product launches and participate in cross-functional core teams.
• Respond to regulatory inquiries from distributors, customers, sales, marketing, and other stakeholders.
• Provide regulatory support for tenders and ensure timely responses to deadlines.
• Represent Regulatory Affairs in internal/external meetings and follow up on actions.
• Provide broader regional regulatory support and maintain shared platforms and reports to RA EMEA.

Conocimientos

Fluent English

Fluent Spanish

Analytical skills

Attention to detail

Problem solving

Independent working

Communication skills

Cross-functional collaboration

Willingness to travel

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.