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Regulatory affairs specialist

Castelldefels
PROCARE HEALTH
Publicada el 1 mayo
Descripción

We’re hiring!


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


Your mission


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.


Key responsibilities


Product Registration & Market Access - Food Supplements + Medical devices

* Support 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.
* Assist in compiling regulatory documentation to support product launches, renewals, and lifecycle management.
* Track regulatory status, submission timelines, and approvals across multiple geographies.


Medical Devices

* Provide support, under supervision, in the preparation and maintenance of regulatory documentation for pharmaceutical products and/or medical devices.
* Assist with selected activities related to product registrations, variations, renewals, or technical documentation updates.
* Support cross-functional data collection for regulatory submissions and compliance maintenance.


Ingredients & Formulation Compliance – Food supplements

* Support 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.
* Support documentation related to ingredient safety and regulatory status.


Labeling, Claims & Product Communication – Food supplements

* Assist in the review of labels, packaging, and marketing materials to ensure compliance with food supplement and natural health regulations.
* Support the assessment of nutrition and health claims, including those related to fertility, hormonal balance, bone health, energy, and menopause support.
* Contribute to the alignment of compliant claims with marketing and brand strategy.


What we’re looking for


* Minimun 2 years of experience in EU medical devices & food supplements
* Understanding of regulatory requirements in other international markets.
* Ability to interpret regulatory texts and guidance documents.
* Experience working with external partners (consultants, distributors, manufacturers).
* Strong attention to detail and compliance-oriented mindset.
* Ability to manage multiple tasks and regulatory timelines.
* Fluent English and Spanish (written and spoken). Additional languages are an asset.


What we offer


* A role within a specialized and purpose-driven women’s health company.
* International exposure and meaningful projects.
* Great work environment.
* Flexible start time to better fit your routine (between 8:30 and 9:30 a.m.).
* Remote work on Fridays from 9:00 a.m. to 2:00 p.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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