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Regulatory specialist and senior specialist

Castelldefels
PROCARE HEALTH
Publicada el 1 mayo
Descripción

At Procare Health, we are a Spanish pharmaceutical laboratory with an international footprint, dedicated to the research, development, and distribution of natural and scientifically proven solutions for women's health and wellbeing .

We are currently looking for a Regulatory Affairs Specialist, a primary role in women's health-focused food supplements and medical devices registration activities

You will support regulatory activities related to food supplements and medical devices for women's health, including fertility, menstrual wellbeing, pregnancy support, perimenopause, and menopause, across Europe and ROW markets .

As a secondary and optional scope, you may also support selected regulatory activities for pharmaceuticals and/or medical devices, depending on business needs and under supervision.

Product Registration & Market Access - Food Supplements + Medical devicesSupport the preparation and submission of food supplement and medical devices notifications/registrations in the EU and selected ROW markets, for Procare Health legal entities and distributors.Medical DevicesProvide support, under supervision, in the preparation and maintenance of regulatory documentation for pharmaceutical products and/or medical devices.Support cross-functional data collection for regulatory submissions and compliance maintenance.

Ingredients & Formulation Compliance – Food supplementsSupport regulatory assessment of formulations containing vitamins, minerals, botanicals, probiotics, and other natural ingredients commonly used in women's health.Assist in verifying compliance with authorized ingredient lists, maximum levels, country-specific restrictions, and novel food considerations where applicable.Assist in the review of labels, packaging, and marketing materials to ensure compliance with food supplement and natural health regulations.Contribute to the alignment of compliant claims with marketing and brand strategy.

Minimun 2 years of experience in EU medical devices & food supplementsStrong attention to detail and compliance-oriented mindset.Fluent English and Spanish (written and spoken). A role within a specialized and purpose-driven women's health company.International exposure and meaningful projects.Remote work on Fridays from 9:00 a.m. Private health insurance.Permanent contract.

If you're passionate about regulatory affairs and women's health, we'd love to hear from you!

Apply now or share this opportunity with your network.

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