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.
As our Post Market Surveillance Specialist, you will focus on our post market surveillance activities, playing a pivotal role in safeguarding customer trust and regulatory compliance across our portfolio. This is an exciting opportunity to combine your analytical skills with impactful decision-making in a dynamic and fast-paced environment.
What to expect:
- Ensure customer complaints are accurately handled from intake to closure, verifying compliance with regulations and procedures.
- Interpret and apply regulatory requirements for vigilance and reporting across global markets.
- Perform complaint file reviews, coding for trending and reporting, and support complaint trending activities.
- Participate in global teams for complaint handling, field actions, and regulatory reporting.
- Write, edit, or develop vigilance documents and templates aligned with corporate procedures.
- Coordinate field actions and reporting with competent authorities and regional teams.
- Ensure health hazard assessments are completed for regulatory reporting of product issues.
- Provide monthly updates on complaint investigations, vigilance reporting, and field action closures.
- Maintain knowledge of evolving regulations, laws, and industry standards.
- Assist with the creation of Periodic Safety Update Reports (PSURs).
- Support customer feedback initiatives and contribute to Quality Management Review meetings.
- Deliver training on Post Market Surveillance and Complaint Reporting to relevant teams.
What we expect:
- Expertise: Associate degree or bachelor’s degree, preferably in engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering
- Knowledge: Relevant work experience in the medical device, IVD or pharmaceutical industries
- Skill: Strong communication skills, with the ability to work in a fact paced environment
- Autonomy: Demonstrates independent decision making and prioritization, including independent resolution of conflicts.
- Adaptability: Flexibility to adapt to changing market conditions, customer requirements, and company priorities.
- Organisation: Strong organisational skills, with experience working in a busy role with numerous deadlines
- Proactive: Ability to anticipate challenges and take initiative to address them.
- Resilience: Maintains a positive attitude and strong work ethic even in challenging situations.
- Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviors.
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-HE1
