Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.  

The Senior Regulatory Affairs Specialist developments and supports the implementation of global regulatory strategies, coordinates registrations to sustain marketing of existing products.

This role enables commercial launch of new products, supports processes, and manages data to assure that all products manufactured and /or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable global regulatory requirements.

This position is a P3 level

What will you be doing?

Prepare NPD regulatory submissions such as 510(k), technical documentation files, design dossiers for new and modified devices.Acts as regulatory representative on cross functional project teams; Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines for new and modified products.Plans and Prepares international dossiers for New Product Development Key strategic markets to obtain and maintain global regulatory approvals of products to meet company product launch times.Reviews and approves product, supplier and manufacturing changes for compliance with applicable regulations and applicable procedures.Reviews and approves device labeling and advertising and promotional materials to ensure continued compliance to global regulations; may lead the development of regulatory strategies for new claims, indications and therapies.Ensures distribution of products within SAP comply with regulatory requirements and liaise with Regulatory PLD specialist to provide updates to licensing and management of SAP license blocks, release requests for registration.Updates and maintains company databases with required information and status for Unique Device Identifier, GUDID, Di, EUDAMED, RIMSYS, licenses, registrations, renewals, products, and other required data to assure compliance with business and Regulatory requirements.Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary. Provides support for internal and Regulatory Agency audits.Provides technical guidance to junior regulatory professionals inclusive of coaching and mentoring and guidance to cross functional teams.Build Quality into all aspects of job performance by maintaining compliance to all quality requirements and participates in training and development activities as required and other duties as assigned.

What will you need to be successful?

Education: Bachelor's degree (BS) or higher degree in Clinical, Medical, or Scientific/Technical Disciplines.Certifications:  RAC Professional certification(s) (preferred).Experience: 5+ years’ experience in global regulatory submissions in a regulated environment (medical device). 3+ years’ Prior experience with Product Development and Design Control Processes and Product Lifecycle Management Systems is preferred.Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus.Languages: Advanced English skills.Knowledge: Proficiency with SAP, Windchill, Agile, RIMSY, Microsoft Office, Adobe, internet is preferred.Read, Understand, and apply global regulations.Technical knowledge of medical products.Knowledge of product development process and design control.Competences: Understanding of relevant procedures, practices, and associated medical terminology.Excellent research and analytical skills; detail oriented Ability to manage multiple projects.Ability to work and problem solve both independently and within a team.Ability to work within deadlines as imposed by government regulations and internal guidelines.Excellent written and oral communication.Demonstrated strategic thinking with the tactical and operational experience to deliver objectives/results.Ability to communicate effectively and work within international multidisciplinary team.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website.

Other reasons why you will love it here!

Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.Work/Life Balance: Extra days off, birthday off, voluntary hours.Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. Flexibility: Hybrid work model (for more professional roles), flexible schedules.Training: Training program, unlimited learning.Extra perks: employees association, and more…

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