Regulatory Affairs Specialist - EMEA
LifeWave•Draper, UT
•Onsite
About The Position
The Regulatory Affairs Specialist for the EMEA region is responsible for all regulatory aspects within the region. This includes, but is not limited to, ingredient review, marketing collateral review, product registrations, and label reviews. The role requires understanding, implementing, and maintaining the quality policy, and ensuring compliance with site and division-level policies and procedures.
Requirements
- Bachelor's degree in business or related field or 4-6 years of experience in regulatory affairs in medical device, cosmetic, food, and dietary supplement field in EMEA.
- Proficiency in Microsoft Suite required.
- Strong attention to detail and time management skills.
- Excellent communication skills, both written and oral.
- High level of observation must be able to learn quickly with an ability to be self-sufficient, motivated and to work independently.
Nice To Haves
- Experience in cosmetic, dietary supplement contract manufacturing a plus.
- Bilingual proficiency is preferred but not required.
Responsibilities
- Responsible for regulatory activities of LW EMEA countries to launch and secure the products in the markets.
- Basic understanding of laws and regulations of the responsible EMEA countries.
- Assisting the department head in responding to all product-related inquiries and actions by regulators and internal departments.
- Assisting in preparing and filing necessary documentation for applications with international government agencies for product registration and coordinating advice on technical aspects of product labeling, product dossiers, claims substantiation/localization, and product registrations.
- Reviewing marketing materials for compliance with advertising law and scientific substantiation.
- Reviewing product labels for compliance with local labeling regulations for medical devices, general wellness, supplements, and cosmetics.
- Manage Regulatory tools and trackers.
- Perform other related duties assigned by department head.
- Obtains supervisory regulatory review on submission documents before submission to government agencies.
- Signs off at the team level within delegated parameters for change control.
- Releases authority for labeling/sales/promotional materials.
- Share knowledge with others in the department.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
