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A Day in the Life

About the Operating Unit / Portfolio / Function
The Regulatory Affairs function supports the registration, maintenance, and regulatory compliance of medical devices across multiple Medtronic business units in Spain. The team works closely with commercial, marketing, quality, supply chain, and tender management teams to ensure product information is accurately maintained and regulatory requirements are met throughout the product lifecycle.

About the Position
This Temporary position is based in Spain and follows a Flex work model with an expectation of regular office presence. The role requires collaboration with local and international stakeholders and supports interactions with the Spanish Agency of Medicines and Medical Devices (AEMPS). Travel is not expected to be a significant component of the role. The Associate Regulatory Affairs Specialist supports regulatory activities related to medical device registrations, product database maintenance, and compliance processes across multiple business units. This role provides exposure to both pre-market and post-market regulatory activities and offers the opportunity to work with cross-functional teams while developing expertise in Spanish and European medical device regulations.

Primary Responsibilities

• Support the registration of new medical devices and updates to existing product registrations within the AEMPS system.
• Maintain and ensure accuracy of regulatory and product information within internal databases.
• Monitor regulatory submissions and support resolution of registration-related issues and deficiencies.
• Prepare and coordinate documentation required for regulatory submissions, renewals, and registrations.
• Collaborate with business units and cross-functional partners to address regulatory requirements and support commercial activities.
• Assist with tracking and reporting of regulatory activities, deadlines, and compliance metrics.
• Support regulatory inspections, audits, and quality system activities as required.
• Monitor regulatory updates and contribute to implementation of new regulatory requirements and processes.

Required Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Engineering, Business Administration, or Industrial Technologies.
• At least 1 year of experience in Regulatory Affairs, medical devices, healthcare, quality, compliance, or a related function.
• Proficiency in Spanish and English, both written and spoken.
• Experience using Microsoft Office applications, including advanced Excel skills.
• Knowledge of regulatory documentation management and strong attention to detail in data administration activities.

Preferred Qualifications

• Knowledge of Spanish medical device regulations and AEMPS registration processes.
• Understanding of European Medical Device Regulation (EU MDR) requirements.
• Exposure to Quality Management Systems, including ISO 13485.
• Experience maintaining databases, regulatory records, or product information systems.
• Experience collaborating with multiple business functions in a regulated environment.

Medtronic is committed to safeguarding the principle of non-discrimination in employment on the basis of sex, sexual orientation or gender identity, as set out in Article 14 of the Constitution and Articles 17 and 18 of the Workers' Statute, as well as Organic Law 3/2007 of 22 March on effective equality between women and men and Law 4/2023 for the real and effective equality of transgender people and the protection of LGTBI rights. This commitment applies to all company personnel without exception. This is done with the understanding and conviction that equal treatment and opportunities in the workplace must be guaranteed, ultimately ensuring an inclusive working environment that advances the eradication of discrimination against LGTBI people and the absence of any direct or indirect discrimination on the grounds of sex, sexual orientation, gender identity and expression, and those derived from maternity, family obligations and marital status.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Spain: 32,000.00 EUR - 48,000.00 EUR |