Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Regulatory Affairs Specialist II is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impacts the introduction of new products and market status of existing products.
The Regulatory Affairs Specialist II will assist Regulatory Affairs management by supporting activities and processes as required to assure that products manufactured and/or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable global regulatory requirements.
What will you be doing?
Prepares international dossiers for EU and other key market affiliates, to obtain and maintain global regulatory approvals of products.
Generates regulatory strategies for new and modified products, product support on change notifications and quality plans for US and international impact assessments.
Provides regulatory support to global regional regulatory teams on international regulatory requirements to support registrations based on new and modified product changes.
Provide customer service necessary regulatory / registration information for compliance and customer requests.
Support manufacturing changes for compliance with applicable regulations, including US, EU and global international via regulatory strategy, assessments, and submission support as needed.
Works with cross functional teams – with senior support - to deliver supporting documentation (IFU, DHF, CER etc.) during dossier creation and during review and approval of labelling and instruction for use based on changes to modified products assessed or notified body inputs.
Ordering and legalization of documentation supporting global RA approvals such as Certificates of Free Sale.
Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e., GUDID, DI, EUDAMED, RIMSYS, and Management of SAP for legal blocks and registrations.
Update and maintain knowledge of current developments and changes to applicable laws, regulations, and industry standards.
Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
Provide support for internal and Regulatory Agency audits.
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?
Bachelor’s degree in Engineering, Biomedical Science, Pharmacy, Medicine, or a related field
Experience: 2+ year(s) Regulatory Affairs medical device industry experience.
Competencies:
Read, Understand, and apply global regulations.
Technical knowledge of medical products
Understanding of relevant procedures, practices, and associated medical terminology.
Knowledge of product development process and design control
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.
Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus
Proficiency with SAP, Microsoft Office, Adobe, internet
Occasional use of Personal Protective Equipment (PPE) required.
Travel Requirements: 5-15% (Domestic and/or International)
You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity 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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