The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Biologics, Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
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.
(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
Bachelor's degree in Biomedical Engineering or Biological Engineering, or equivalent discipline preferred.
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
Minimal lifting of documentation (i.e. carrying laptop or binders of documentation.)
Internal Number: R49054
About Smith & Nephew
At Smith+Nephew, we design and make technology that takes the limits off living, and we help healthcare professionals achieve the same goal. Together we improve life, while also improving performance.
Life Unlimited. Smith+Nephew exists to restore people’s bodies and their self-belief.
Our global franchise areas include:
Orthopaedics includes an innovative range of Hip and Knee Implants used to replace diseased, damaged or worn joints, robotics-assisted enabling technologies that empower surgeons, and Trauma products used to stabilise severe fractures and correct bone deformities.
Sports Medicine & ENT
Our Sports Medicine and Ear, Nose and Throat (ENT) businesses offer advanced products and instruments used to repair or remove soft tissue. They operate in growing markets where unmet clinical needs provide opportunities for procedural and technological innovation.
Advanced Wound Management
Our Advanced Wound Management portfolio provides a comprehensive set of products to meet broad and complex clinical needs, to help healthcare professionals get CLOSER TO ZERO human and economic consequences of wounds