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Job Description

Serve as the engineering and technical point of contact for the offshore facility

Collaborates with operations, maintenance, & construction personnel to identify, develop & implement offshore brownfield projects

Organizes and leads cross-functional teams to address complex issues or technical activities

Coordinates offshore construction and complex maintenance support vendors to ensure the highest level of safety, environmental, quality, & regulatory performance.

Verifies offshore equipment is installed and operates within company specifications, applicable regulations, industry codes, & Recognized and Generally Accepted Good Engineering Practices (RAGAGEP)

Develops and reviews relevant engineering and construction execution documents such as P&IDs, Construction Execution Workpacks, Risk Assessments, Piping Isometrics, Execution Schedules, Commissioning, Startup & Operations Procedures

Works in collaboration with stakeholders to clearly define project scope and objectives during the project development phase

Reviews EPC Contractor deliverables and ensure consistency with Design Specification for assigned facilities

Drives small project execution schedules within operating requirements and company business

objectives

Monitors project financial performance within planned company budget and overall business outcomes

Leads Facility system optimization efforts, defect elimination, and root cause analysis investigations

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
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely 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
Monitor and document post marketing activities, analysis of trends, vigilance processes.
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

we are looking for a Sr. NPI Technical leader.
The Sr NPI Engineer will be responsible to represent the Operation and lead new projects and transfer them to production including the following:
E2E OPS rep for all New Products Introduction cross functional, following PLCM.
Responsible for building Product/Production file, Product documentation, BOM, jigs/tools/Fixtures design
Manage TK vendors and Critical vendors
Responsible for moving from prototype to mass production, including PL establishment and manufacturing strategy
Responsible of full Design transfer process during the PLC stages.
Full cooperation under Program and Project managers guidance