Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 5/21/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Regulatory Affairs Specialist
Industry: Medical Devices
Location: Marlboro, MA
Employment Type: Full Time, Contract
Pay Range: 45-60/hr.
Duration: 12 months+
Regulatory Affairs Specialist
Responsible to develop corporate procedures for labeling, UDI and EUDAMED in compliance with all key internal and external global regulatory requirements including EU Medical Device Regulation (MDR) and Invitro Device Regulation (IVDR).
Description/ Job Summary
• Works collaboratively with the divisional representatives to gather feedback on new processes to ensure alignment and to better support their business.
• Works with the Information Services (IS) team to identify changes needed into the systems to support new requirements.
• Provides oversight and reports progress to all activities under responsibility to ensure compliance with defined due dates.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Responsible for the development of corporate SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR and IVDR.
• Ensures all corporate procedures impacted by the new procedures are identified, assessed for updates, changes needed and that these changes are completed as appropriate.
• Develops training material and provides training to divisional SMEs (Subject Matter Experts) to support the effective implementation of the new process.
• Develops and maintain a quality plan to define all key milestones needed to develop the procedures, system changes, validation etc. to maintain the integrity of the Corporate Quality Systems during the implementation of these new processes.
• Develops and maintains a detailed project plan if needed to support these activities.
• Provides periodic updates on progress, accomplishments, risks and mitigation plans related to the new processes.
• Maintains periodic and effective communication with the divisional and corporate teams involved in the development of the new processes.
• Works with the Information Services (IS) team to identify systems changes needed to support the new requirements.
• Ensures all requirements are clearly communicated to the divisions proactively.
• Ensure all activities are completed on time according to established dates.
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776