| Role Overview: This role will be focused on, Regeneten, one of the fastest growing and exciting product lines at Smith+Nephew that involves novel absorbable and non-absorbable implant and delivery technologies to serve our patients and customers in the shoulder repair market. This position is ideal for an experienced regulatory professional capable of providing technical contribution and leadership on medium scale projects and / or multiple projects. The candidate will be required to build strong relationships across the organization to shape the direction of the product and therapy. Through coordination/collaboration with direct supervisor and, with limited direction, your job as a Senior Regulatory Affairs Specialist will be to: -
Develop global regulatory strategy and coordinates associated registration or submissions leading to market clearance/approval. -
Provide regulatory direction to project teams for product development/design control related activities. -
Ensure regulatory compliance throughout the life-cycle of the product by assessing product changes for impact to registrations/licenses. -
Maintain databases as required and support regulatory compliance projects as assigned. Responsibilities: -
(10%) Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams -
(30%) Develops and implements regulatory strategies for new and modified products and regulatory processes, and prepares submissions to obtain and maintain global regulatory approvals of products, providing oversight of device labeling and advertising and promotional materials to ensure continued compliance to global regulations -
(5%) Prepares for and assists with external audits such as MDSAP or Notified Body technical audits -
(30%) Provides regulatory guidance and direction as a core team member on development and manufacturing teams, as well as compliance projects, throughout the product development life-cycle, and identifies/coordinates cross functional deliverables -
(10%) Reviews and approves product and manufacturing changes for compliance with applicable regulations -
(10%) Prepares, reviews, and maintains technical documentation including Design Dossiers and Technical files, and works with relevant team to resolve issues -
(5%) Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
Location:
Andover, MA Education: Bachelor's degree in Biomedical Engineering or Biological Engineering, or equivalent discipline preferred. Licenses/ Certifications: RAC Preferred Experience: -
5 or more years in Regulatory Affairs with Product Development experience. (Required) Experience with implantable or novel devices preferred. -
Experience with Regulatory compliance, Global Submissions, 510K, Product development, Change Controls, Technical Documentation creation and maintenance and process management -
Knowledge and practical application of medical device product development regulations (ISO, GMP, FDA, CE, EU MDR) and design controls -
Experience in Biologics, FDA Q-Sub, Internal/External Audits, Quality Systems expertise and clinical trial experience beneficial -
Strong communication ability Physical Demands: Minimal lifting of documentation (i.e. carrying laptop or binders of documentation.) Travel Requirements: <10% |
