Regulatory Affairs Specialist

Spain·Comunidad De Madridmid

Legal & ComplianceRegulatory Affairs Specialist

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Quick Summary

Overview

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,

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Legal & ComplianceRegulatory Affairs Specialist

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.

Requirements

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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%).

What We Offer

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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.