Senior Post Market Suveillance Analyst

Hologic; 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

Senior Post Market Suveillance Analyst

Zaventem, Vlaams Brabant, Belgium

As a leading innovator of women's health, we at Hologic are empowering people to live healthier lives everywhere, every day.

Our Quality teams play a critical role in protecting patients, customers and our business by ensuring we meet the highest standards of quality, compliance and regulatory excellence. They help us maintain customer trust, support market access, and ensure our products continue to meet global regulatory expectations throughout their lifecycle.

As our Senior Post Market Surveillance Analyst , you will be responsible for key post market surveillance activities, with a particular focus on complaint handling, vigilance reporting and the coordination of Field Safety Corrective Actions across the EMEA region. This is an exciting opportunity to use your technical knowledge, regulatory understanding and stakeholder management skills to make a direct impact on patient safety, compliance and customer confidence.

What to expect:

• Coordinate the implementation of Field Actions, including Field Safety Corrective Actions, across the EMEA region.

• Oversee assigned field actions from initiation through to completion, ensuring timely progress and closure.

• Prepare required documentation, including FSCA reports, Field Safety Notices, customer lists and related materials.

• Submit Field Safety Corrective Actions to Competent Authorities and coordinate follow-up communications.

• Ensure field action and post market surveillance activities comply with regulatory requirements and internal procedures.

• Participate in and lead cross-functional meetings and projects relating to field action activities.

• Manage communication with affected parties, including Hologic employees, dealers and distributors.

• Maintain knowledge of current and proposed regulations, laws, guidelines, standards and initiatives relating to field actions and post market surveillance.

• Support internal and external audits as required.

• Support wider post market surveillance activities, including complaint handling and vigilance reporting.

• For customer complaints, interpret and apply applicable regulations to ensure compliance with vigilance and reporting requirements.

• Ensure complaint handling activities are completed accurately from opening through verification and closure.

• Write, edit and develop vigilance and reporting documents, templates and related materials in line with corporate procedures.

• Provide monthly reporting to regional management on complaint investigations, vigilance reporting and field action closures.

• Perform other related duties as assigned.

What we expect:

• Expertise: Bachelor's degree in biological sciences, life sciences or a related discipline.

• Experience: Experience in the medical device, IVD or pharmaceutical industry, including experience in a field action or complaint handling role.

• Regulatory knowledge: Understanding of applicable international medical device regulations and standards, such as ISO 13485, MDR/IVDR, CFR 803 and CFR 820, would be preferred.

• Vigilance experience: Experience interfacing with Competent Authorities responsible for vigilance activities would be preferred.

• Communication: Solid written and verbal communication skills, with the ability to communicate clearly, professionally and effectively with internal teams, external partners and medical personnel.

• Languages: Fluency in English is required; working knowledge of another language would be an advantage.

• International mindset: Experience working in an international environment.

• Autonomy: Ability to independently plan, execute and problem-solve in moderate to complex situations.

• Judgment: Ability to exercise sound judgment within defined practices and policies when selecting methods and solutions.

• Collaboration: A team player who demonstrates initiative, balanced assertiveness and professionalism.

• Organisation: Ability to manage multiple projects and priorities in a busy environment with competing deadlines.

• Adaptability: Flexibility to adapt to changing regulatory requirements, business priorities and customer needs.

• Continuous Learning: Commitment to staying current with evolving regulations, standards, industry expectations and best practices.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required, so we provide comprehensive training when you join, as well as continued development and training throughout your career.

We look forward to hearing from you!

Salary: €64,000 - €77,000 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.

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