Senior Post-Market Surveillance & Compliance Lead

Hologic, Inc.; Zaventem; On-site; EUR 64,000 - 77,000; Full time

Job summary

Hologic, Inc. in Zaventem, Belgium, seeks a Senior Post Market Surveillance Analyst to lead post-market activities, with focus on complaint handling, vigilance reporting and coordinating Field Safety Corrective Actions across the EMEA region.

You will ensure regulatory compliance, collaborate with internal teams and external partners, and support audits. English fluency is required; an international mindset and autonomy are essential in a dynamic environment.

Qualifications

• Bachelor's degree in biological sciences, life sciences or a related discipline.
• Experience in the medical device, IVD or pharmaceutical industry.
• Understanding of ISO 13485, MDR/IVDR, CFR 803 and CFR 820.
• Vigilance experience interfacing with competent authorities would be preferred.
• Fluency in English is required; working knowledge of another language is an advantage.
• Experience working in an international environment.
• Autonomy in planning and solving problems.
• Sound judgment within defined practices.
• Team player with initiative and professionalism.
• Strong organizational skills with multiple priorities.
• Ability to adapt to changing regulatory requirements.
• Commitment to ongoing learning and keeping up with regulations.

Responsibilities

• Coordinate Field Actions across the EMEA region from initiation to completion.
• Prepare FSCA reports, Field Safety Notices and related materials.
• Submit FSCA to authorities and coordinate follow-up communications.
• Ensure compliance with regulatory requirements and internal procedures.
• Lead cross-functional meetings related to field action activities.
• Manage communications with employees, dealers and distributors.
• Maintain knowledge of current and proposed regulations and standards.
• Support audits and post market surveillance activities.
• Interpret regulations for customer complaints and ensure proper vigilance handling.
• Provide monthly reporting on investigations, vigilance, and field action closures.
• Perform other related duties as assigned.

Skills

English proficiency

Education

Bachelor's degree in biological sciences or life sciences

Job description

Hologic, Inc. in Zaventem, Belgium, seeks a Senior Post Market Surveillance Analyst to lead post-market activities, with focus on complaint handling, vigilance reporting and coordinating Field Safety Corrective Actions across the EMEA region.

You will ensure regulatory compliance, collaborate with internal teams and external partners, and support audits. English fluency is required; an international mindset and autonomy are essential in a dynamic environment.