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In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities:
In this role, you will
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Coordinate and implement MDR requirements related efforts in the organization.
Assess product changes and their global regulatory impact.
Lead or compile all materials required in submissions, license renewal and annual registrations for internal and external partners.
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW).
Identify and communicate regulatory risks and mitigations.
Respond to Information requests from regulatory Authorities.
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities.
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes.
Coordinate project submission timelines in multiple regions.

We are seeking an experienced and highly motivated Lab engineer to run the planning, build-out, and operation of our state-of-the-art laboratory environments.In this role, you will drive the design and setup of lab infrastructure to support cutting-edge hardware and software development, ensure compliance with the highest safety standards, and oversee inventory and operational excellence.You will collaborate closely with lab engineering, research, and facilities teams to enable innovation at scale.
Join us on this exciting journey as we build and operate state-of-the-art lab environments that empower innovation and discovery.
What Youll Be Doing:
Plan, design, and manage the construction and commissioning of new lab spaces to support advanced R&D activities.
Develop and enforce lab safety protocols in accordance with organization policies and relevant regulations.
Oversee day-to-day lab operations, ensuring that all equipment, systems, and processes are running smoothly.
Manage lab inventory and procurement processes, including sourcing, vendor management, and stock control.
Supervise maintenance, calibration, and certification of lab equipment and infrastructure.
Support engineering teams with technical setups, system configurations, and troubleshooting.
Lead and mentor lab operators and support staff, fostering a culture of safety, quality, and continuous improvement.
Maintain accurate documentation, reporting, and compliance records.