Company Description
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Experience:
- 7+ years of experience and area specialty is in Medical Devices (IVD/IVDR).
POSITION SUMMARY:
The Sr.Manager, Regulatory and Strategic Development, will be responsible for developing and implementing
regulatory strategies for client projects (Role focus will be 50% RA, 25% on RIM/UDI and other time on
Adhoc med device and diagnostics aspects). The incumbent will be responsible for the strategy and
preparation 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 and
management of regulatory professionals and support personnel.
Job Duties and Responsibilities:
- Create, monitor and maintain timelines for client strategic development, submission management and regulatory affairs programs.
- Develop and execute global strategic plans (regulatory and/or quality systems) for the development of client medical device development programs.
- Act as subject matter expert 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 changes in regulations and communicates to appropriate personnel. Shows an understanding of the changing
- regulatory environment and the impact on business practices, policies and projects and demonstrates an 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 the organization’s policies and applicable laws.
- Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Manages applicable portions of established departmental budget, using good judgment to ensure that costs are appropriate and reasonable and that any foreseen overages are communicated for transparency.
Other:
- Ability to perform business travel (local/international), up to 25%
- All other projects as assigned