Easter Seals Jobs

Senior Regulatory Affairs and Design Assurance Engineer

Denmark

Berlin, Germany

Belgium

This job is a contract position for a specific project with an estimated timeline of 2 years.

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

Our regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs to influence strategic and operational plans.

As our Senior Regulatory Affairs and Design Assurance Engineer, you will be leading a truly exciting project within our Breast & Skeletal Health division. You will hold primary responsibility for compliance with US, EU and Canadian regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for medical devices.

This role also serves as a Design Assurance Engineer for the project and will be working closely with the Design Assurance team to ensure alignment and compliance to Design Controls, Risk Management and our Quality Management System

What To Expect:

• Support product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing US promotional materials, and ensuring that documentation is current and accurate from a regulatory perspective.

• Perform the coordination and preparation of document packages for regulatory submissions for new products to ensure alignment and compliance with US, EU, and other international registration requirements

• Compile all materials required in submissions, license renewal and annual registrations.

• Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.

• Support all activities that Design Assurance is Responsible, Accountable, and Consulted for during product development or product transfers (acquisitions) including, design input requirements, design outputs, verification, validation, design transfer, and clinical preparation, where applicable.

• Execute Risk Assessments in support of new product development programs as well as implementation and maintenance of Risk Management throughout the device product life cycle.

• Manage and maintain regulatory databases and technical files.

• Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated.

• Direct interaction with regulatory agencies on defined matters.

• Recommends strategies for earliest possible approvals of clinical trials applications.

• Collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

• Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

• Ensure safety and effectiveness are designed into and maintained in medical devices, through expertise in design control, risk management, quality systems and change management.

• Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance

What We Expect:

• Bachelor's Degree (Engineering, Biomedical or related field preferred)

• Considerable experience in both regulatory affairs and design assurance

• Experience with the creation of technical files and documentation

• Experience working in regulated medical device industry.

• Working knowledge of EU Medical Device Regulation, Regulation (EU) 2017/745

• Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA and foreign regulatory requirements

• Strong data and statistical analysis skills and ability to use data to make informed recommendations

• High degree of attention to detail

• Regulatory Affairs Certification (RAC)

• Project Management Experience

• FDA ESTAR experience (advantageous)

• Ability to drive action in accordance with Deming Cycle (PDCA) Principles

• Working knowledge of verification and validation requirements for a regulated product

• Working knowledge of requirements analysis, including development of testable and measurable specifications

• Experience with Good Laboratory Practices

• Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment

What We Offer:

• A dynamic work environment where your ideas lead to tangible impacts.

• Competitive salary and benefits package, including health insurance.

• Opportunities for professional growth and development within a global company.

• A supportive, diverse, and inclusive culture focused on innovation and teamwork.

Ready to join a company where your work will help shape the future of women’s health? Apply now.

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