Regulatory Affairs and Quality Assurance Specialist
4 weeks ago
At Hologic, Inc., we are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team. As a leading innovator of women's health, we empower people to live healthier lives everywhere, every day.
Our quality and regulatory affairs team is responsible for staying up-to-date on new, changing, and existing regulatory requirements. They develop and implement a global vision for regulatory affairs, government relations, quality management, and market access, influencing strategic and operational plans.
As our Quality Assurance and Regulatory Affairs Specialist, you will provide support to acquired company sites for on-market medical devices remediation and support. You will facilitate reviews of QMS systems with a risk-based approach and prepare for harmonization, enabling you to offer support and guidance to action items within the Integrated Quality Plan.
- Assess change requests of products for impact to design, determine supporting information required for implementation of changes.
- Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.
- Review risk documentation for adequacy and update risk files into the Hologic templates.
- Work collaboratively with R&D to coordinate design elements of Risk Management files for products to assure compliance with applicable standards and internal procedures/policies.
- Ensure the accuracy of data collected and thorough investigation of complaints.
- Work closely with R&D, Manufacturing, Service, and Supplier Quality to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.
- Assist with quick and effective resolution to quality issues, including ship hold and field actions.
- Assist with managing field actions, including regulatory and field communication, and execution of deliverables.
What We Expect
- Expertise: Bachelor's Degree, preferably in an engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering.
- Knowledge: MDSAP, EU Medical Device Regulation, US/EU Medical Device Reporting and Vigilance.
- Skill: Strong analytical skills, including trend and statistical analysis, interpersonal, and management skills.
- Experience: A significant and demonstrable track record of managing projects in a medical device, pharmaceutical, or heavily regulated industry.
- Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements.
We are committed to making Hologic, Inc. 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. This is a 12M Fixed Term Contract Position.
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