The role is critical in supporting all regulatory activities in MEA and meeting aligned objectives.
Accountable for creating Regulatory submissions in terms of content, according to local regulations and requirements for assigned markets. Ensure documents (Example: electronic, paper copy) are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready. Ensures the processes transparency and excellence in execution of regulatory strategies. Maintain systems and databases per internal SOPs and policies. Work in collaboration across the regulatory organization with stakeholders to deliver efficiencies in Regulatory submissions and processes.
- Manage submissions for assigned market(s) as per the submission plan
- Ensure internal regulatory processes and procedures are followed
- Assist RA Lead to improve efficiencies across the region through achieving timely submissions and approvals
- Understand local regulations and trends for assigned markets
- Regulatory Submissions as per regulatory plan (Retreive documents needed for regulatory submission from regulatory database/ Request missing documents from Divisional RA and review them/Compile all documents needed for submission for review by the RA team./Submit to distributors the ready to submit file and ensure follow up with the distributors that actual submission is made)
- Regulatory Approvals and maintenance ( Collect queries from distributors and follow instructions from RA team to respond in timely fashion /Archive all submissions and approvals)
- Improve efficiencies (Track all submissions made by date and approvals received by date /Update needed reports/Share traffic light reports with the region)
- Support in creating documents needed for customs release (Declaration of Conformity/Sterilization Certificate)
Technical Skill Requirements:
- Demonstrate regulatory experience with a medical device background (regional experience is a plus)
- Technically competent to understand submissions, interpret and communicate requirements, and identify potential risks.
- Communication skills
- Able to manage short deadlines
- Team player
- Analytical thinking