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Smith & Nephew: Sr. Regulatory Affairs Specialist

Smith & Nephew

This is a Contract position in Andover, MA posted November 21, 2020.

ABOUT USSmith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients.

We do this by taking a pioneering approach to the design of our advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.We have leadership positions in:Orthopaedics Reconstruction joint replacement systems for knees, hips and shouldersAdvanced Wound Management wound care treatment and prevention products used to treat hard-to-heal woundsSports Medicine minimally invasive surgery of the jointTrauma & Extremities products that help repair broken bonesWe have around 16,000 employees around the world.

Annual sales in 2016 were more than $4.6 billion.

We are a constituent of the UK’s FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN)SUMMARYThrough coordination/collaboration with direct supervisor and with limited direction, develops global regulatory strategy and coordinates associated registration or submissions leading to market clearance/approval.

Provides regulatory direction to project teams for product development/design control related activities.

Ensures regulatory compliance throughout the life-cycle of the product by assessing product changes for impact to registrations/licenses.

Maintains databases as required.

Supports regulatory compliance projects as assigned.RESPONSIBILITIESMaintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.

Provides support for internal and Regulatory Agency audits and may participate in regulatory advocacy and intelligence projects.Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams for global market registrations, such as China, Japan, Singapore, etc.Provides regulatory guidance and direction as a core team member on development and manufacturing teams of electro-medical devices, as well as compliance projects, throughout the product development life-cycle, and identifies/coordinates cross functional deliverables and support for submissions.Develops and implements global 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.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.Reviews and approves product and manufacturing changes for compliance with applicable regulations.Other activities as assignedREQUIREMENTSEducation: Biomedical Engineering, Biological Engineering, or equivalent discipline preferred.Licenses/ Certifications: RAC PreferredExperience: 5 years in Regulatory Affairs with Product Development experienceCompetences: Regulatory compliance, Product development, Change Controls, Technical Documentation creation and maintenance, International registrations, process management.Physical Demands: Minimal lifting of documentation (i.E.

carrying laptop or binders of documentation.)Travel Requirements: ≤10%Smith and Nephew is an Equal Opportunity/Affirmative Action Employer.

Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.