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Sr. Regulatory Specialist
Posted on Jun 26
Sr. Regulatory Specialist
Plainsboro, NJ & North Billerica, MA
The Sr. Regulatory Affairs Specialist will develop and implement global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. This individual prepares on time medical device submissions for US and EU. This individual facilitates timely regulatory clearances/approvals. This individual represents regulatory affairs on project/product development teams. This individual reviews and approves product/facility change orders and labeling/promotional material. This individual assists with international registration requests to support international growth. This individual works with their manager to prioritize regulatory workload based on compliance and business objectives. This individual works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.
• Supports Regulatory Vice President, Regulatory Director and Regulatory Managers in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
• Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
• Participates in health hazard assessments and regulatory field actions
• Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups
• Develops and coordinates global regulatory strategies and regulatory plans
• Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
• Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
• Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications
• Coordinates and prepares responses to FDA/NB or other such regulatory agency letters.
• Prepares 510(k) Decision Trees as required to support engineering change orders
• Reviews and approves product labeling changes
• Reviews and approves promotional literature and marketing materials
• Reviews and approves rework of non-conforming product
• Reviews and approves supplier quality files/documents
• Reviews and approves Medical Device Reports (MDR)
• Support CAPA closure
• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
• Participates in regulatory audits/inspections as required
• Writes SOPs and train key personnel as needed
• Perform other duties as assigned
This individual must have at minimum a Bachelor’s degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in preparing global regulatory strategies for medical devices. This individual must have proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications
. This individual must possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies. The individual must have strong writing, data analysis, and communication skills. The individual must have the ability to handle multiple demanding projects.
A Bachelor’s degree (or international equivalent degree) in biology, chemistry, engineering or related technical field is desired. Equivalent work experience will be considered
Mechanical Engineering Degrees
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