Position summary
Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Ensure compliance to regulation and standards.
Who we want:
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do:
Assists in the preparation and sending of Annual postmarket reports
Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
Support assessment and execution of product field actions
Reports Product field actions to regulatory authorities as required, to comply with local, regional, and global regulations
Engage and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
Develop understanding of risk management practices and concepts.
Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities
What you will need:
BS in a science, engineering or related discipline (Level 8).
0+ years experience in Quality Management Systems
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Travel Percentage: 10%