Regulatory Affairs Specialist- EMEA Region

Remote, USA Full-time
About the position The Regulatory Affairs Specialist (EMEA) plays a key operational role in supporting regulatory compliance, product registration, and documentation processes across Partner.Co’s European markets. This role ensures that products comply with applicable EU and national regulations by coordinating submissions, maintaining regulatory documentation, and collaborating closely with cross-functional teams including Product Development, Quality, Marketing, and Global Regulatory Affairs. The position sits within an international regulatory team and contributes directly to maintaining Partner.Co’s compliance standards, brand integrity, and sustainable growth across existing and future EMEA markets. Responsibilities • Prepare, compile, and maintain regulatory documentation and technical files for product registrations across EU and EEA markets. • Coordinate and support submissions to competent authorities and notified bodies in line with applicable EU legislation (e.g. MDR, IVDR, REACH, CLP, EFSA or similar frameworks). • Review and approve product labelling, packaging, claims, and promotional materials to ensure regulatory compliance. • Monitor and interpret regulatory developments across EU markets and communicate relevant changes internally. • Maintain internal databases and tracking tools for registrations, renewals, and post-market compliance activities. • Collaborate with cross-functional teams to support new product launches, formulation changes, and market expansion initiatives. • Support internal and external audits and contribute to continuous improvement of regulatory processes and systems. • Perform other regulatory and compliance duties as required. Requirements • Strong understanding of EU regulatory frameworks and product compliance requirements. • Proven ability to manage multiple regulatory submissions and priorities simultaneously. • High attention to detail and accuracy in documentation and reporting. • Strong communication and collaboration skills within international, cross-functional teams. • Ability to interpret complex regulatory requirements and apply them pragmatically. • High ethical standards and commitment to confidentiality. • Fluency in English (written and spoken); additional European languages are an advantage. • Proficiency in Microsoft Office and familiarity with regulatory or document management systems. • Bachelor’s degree (or equivalent) in Life Sciences, Chemistry, Pharmacy, Nutrition, or a related discipline. • Minimum of 3–5 years’ experience in Regulatory Affairs within the EU region. • Proven experience supporting regulatory submissions and maintaining product compliance. Nice-to-haves • Experience in the direct selling or multi-level marketing (MLM) industry is an advantage, but not required. • Experience liaising with EU competent authorities or notified bodies is desirable. • Familiarity with MDR, IVDR, REACH, or similar regulatory frameworks is preferred. Benefits • Health Benefits - Including Medical, Dental, and Vision insurance, as well as HSA contributions • Flexible Paid Time Off – Take the time you need, plus 11 company holidays! • 401(k) - We match 100% up to 3% of your contribution, and then another 50% up to 5% of your contribution. We guarantee Safe Harbor immediate vesting. • Mental Health Benefits - All employees have access to our Employee Assistance Program (EAP), giving you free mental health resources and helpful tools. • Supplemental Benefits - Including 100% company paid Basic Life & AD&D insurance and long & short-term disability coverage. • Effective Products – Gain access to our full range of health & wellness products. Apply tot his job
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