Job Description

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

Our quality and regulatory affairs teams are responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence strategic and operational plans.

The Field Action (FA) Coordinator will be primary responsible for field action implementation in the region. The field action coordinator may support other post-market surveillance activities, not limited to complaints or vigilance reporting.

What to expect:

• Coordinate implementation of Field Actions (Field Safety Corrective Actions) in EMEA region
• Oversee assigned field actions from initiation to completion
• Prepare required documentation (FSCA report/FSN/customer list, etc.)
• Submit FSCAs to the Competent Authorities and coordinating consequent communication
• Ensure compliance with regulatory requirements and organizational policies
• Participate in cross-functional projects/ meetings for the FA related issues
• Manage communication with affected parties
• Support internal and external audits
• If required, support other post market surveillance activities, including complaints handling
• Assist in complaint trending activities.
• Support business in customer feedback.
• Write and/or edit vigilance/reporting documents or create new templates in compliance with corporate procedures.
• Provide monthly reporting to regional management on the status of complaints, vigilance reporting and field action closures.
• Direct interface with Hologic employees, dealers and distributors regarding complaints and field actions.
• Maintaincurrent knowledge of current and proposed regulations, laws, guidelines standards, and initiatives.
• Maintain knowledge of current and proposed regulations, laws, guidelines standards, and initiatives in relation to FAs.

What we expect:

• Minimal Bachelor degree in biological sciences, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 2 years’ experience in medical device/IVD or pharmaceutical industries; with at least 1 of those years in a field action or complaint handling role.
• Technical knowledge related to IVD’s would be an advantage.
• Experience working in an international environment.
• Preferred experience interfacing with competent authorities in charge of vigilance activities.
• Fluent in English, a working knowledge of other language, for example French, Spanish or German would be an advantage.
• Preferred knowledge of applicable regulations and standards related to medical device internationally. (ISO-13485, MDR/IVDR, CFR803, CFR820, …)
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Must demonstrate initiative, balanced assertiveness working as a team player.
• Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel.
• Ability to manage multiple projects.

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 and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Our talent partners can discuss our salary offering and any relevant bonus schemes with you.

We look forward to hearing from you!

#LI-RH1