Sr.Manager, Regulatory & Technical Development
POSITION SUMMARY:
The Sr.Manager, Regulatory and Strategic Development, will be responsible for developing and implementingand regulatory strategies for client projects (Role focus will be 50% RA, 25% on RIM/UDI and other time onadhoc med device and diagnostics aspects).
The incumbent will be responsible for the strategy andpreparation of regulatory and labeling related projects for the US FDA, EU and ROW regulatory authorities.
The position will include client and regulatory authority liaison. The position will include the supervision andmanagement of regulatory professionals and support personnel.
Job Duties and Responsibilities:
Create, monitor and maintain timelines for client strategic development, submission management andregulatory affairs programs.
Develop and execute on global strategic plans (regulatory and/or quality systems) for the developmentof client medical device development programs.
Act as subject matter expect in certain areas of EU MDR / IVDR
Establish and direct cross-functional teams of internal and external personnel to deliver client projects.
Support Regulatory Operations / Submission management Automation / IT efforts
Provide training for in-house personnel and supervise the assigned Regulatory staff as needed.
Participate in meetings with regulatory authorities
Monitors activities of applicable regulatory agencies and industry organizations to identify any changesin regulations and communicates to appropriate personnel.
Shows an understanding of the changingregulatory environment and the impact on business practices, policies and projects and demonstratesan ability to discuss relevant points in a diverse forum in more general terms.
Supervisory Responsibilities:
Directly supervises employees assigned. Carries out supervisory responsibilities in accordance with theorganization’s policies and applicable laws.
Responsibilities include interviewing, hiring and trainingemployees; planning, assigning and directing work; appraising performance; rewarding and discipliningemployees; addressing complaints and resolving problems.
Manages applicable portions of established departmental budget, using good judgment to insure thatcosts are appropriate and reasonable and that any foreseen overages are communicated for transparency.
Other:?