Regulatory Compliance Specialist II
hace 1 semana
Company Overview
At Smith+Nephew, we strive to push the boundaries of medical technology. Our mission is to create innovative solutions that improve patient lives.
Job Description
The Regulatory Affairs Specialist II plays a vital role in ensuring compliance with regulatory requirements for our medical devices. This position involves supporting the development and implementation of regulatory strategies, preparing international dossiers for EU and global market affiliates, and generating regulatory strategies for new and modified products.
Key Responsibilities:
- Preparation of international dossiers for EU and global market affiliates.
- Development of regulatory strategies for new and modified products.
- Assistance with change notifications and quality plans for US and international impact assessments.
- Providing regulatory support to global regional regulatory teams on international regulatory requirements.
- Support manufacturing changes for compliance with applicable regulations.
Requirements
- Bachelor's degree in Engineering, Biomedical Science, Pharmacy, Medicine, or a related field.
- 2+ years of experience in the Regulatory Affairs medical device industry.
- Technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology.
Benefits
At Smith+Nephew, we value our employees and offer a range of benefits to support their well-being and career growth. These include training programs, unlimited learning opportunities, hybrid work models, flexible schedules, extra days off, birthday off, voluntary hours, company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave, stock purchase program, referral bonus, subsidy in transport and food, recognition program.
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