Under direction from the Director, Regulatory Affairs, the Sr. Regulatory Affairs Specialist will be responsible for:
· Leading and supporting pre-/post-market regulatory activities for assigned devices, projects, and product changes.
· Performing regulatory impact assessments for design, labelling, packaging, supplier, and manufacturing changes to determine appropriate regulatory pathways and submission requirements.
· Preparing, compiling, and coordinating regulatory submissions and change notifications, including PMAs, PMA supplements, amendments, annual reports, and other change notifications or submissions.
· Supporting regulatory authority interactions by drafting correspondence, coordinating response strategies, tracking submission progress, and preparing responses to requests for additional information.
· Partnering with project teams to define regulatory requirements, review supporting documentation, and help ensure development and change activities are aligned with applicable regulatory expectations.
· Reviewing documentation and evidence that may support regulatory activities, including verification and validation documentation, risk management documentation, and change records.
· Contributing to departmental process improvements, regulatory intelligence activities, and internal tools or procedures that improve consistency, compliance, and efficiency.
· Providing training and support to other members of the department.
· Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies