Strategic Regulatory Affairs Specialist - Southern Europe

Hologic, Inc.; Madrid; On-site; EUR 40,000 - 50,000; Full time

Benefits offered by this job

Pension plan

Insurance coverage

Career development

Job summary

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.

Qualifications

• 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%.

Responsibilities

• 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.

Skills

Fluent English

Fluent Spanish

Analytical thinking

Problem solving

Self-motivated

Well-organised

Effective communication

Tools

Outlook

Word

Excel

PowerPoint

Job description

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.