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Regulatory Affairs Specialist
1 miesiąc temu
Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Regulatory Affairs Specialist is responsible for representing and supporting the regulatory activities in NON EU-CEE Export Markets.
What will you be doing:
Provide accurate, timely and balanced Regulatory Affairs support to the business including providing customers with all the documents necessary for local regulatory activities. Provide answers to technical and regulatory enquiries from customers and/or colleagues to support their business activities and meet requirements as well as provide information and documents for specific requests (clinical data, literature references, statements) and translation of the documents. Develop and manage product databases to include product’s EC documentation required for product registration with the competent authorities in the cluster. Review and approve advertising and promotional material, including product labelling, conference material, and product claims for regulatory compliance. Ensure the compliance, efficiency and clarity of the regulatory processes and procedures to GDP, ISO 9001 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices, review and update existing procedures/work instructions or create the new one if required. Interacting and liaising with Competent Authorities as part of the field action, vigilance and post-market surveillance activities Keep up to date with changes in regulatory legislation and guidelines.What will you need to be successful?
Minimum 1-year experience in regulatory affairs, ideally with medical devices Knowledge of Medical Device Regulation (EU) 2017-745 and other applicable laws and regulations of NON EU Export Market Countries for medical devices and medicinal products. Knowledge of ISO 9001. Operational experience to deliver objects/results, proven ability to influence cross-functional teams Be fluent in English both written and spoken. Polish, Ukrainian or Russian are nic to haveYou. 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 our Employee Inclusion Groups on our website
Your Future: annual bonus, life insurance, company stock saving plan
Work/Life Balance: paid volunteering hours, flexible approach
Your Wellbeing: private health care with dental care package, multisport card/my benefit platform
Flexibility: possibility of working in hybrid model
Training: Hands-On, Team-Customized, subsidies for language classes, certifications and postgraduate studies
Extra Perks: referral bonus, recognition program, mentoring program
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