Senior Regulatory Affairs Program Lead & Deputy Technical Responsible, Spain

Essential duties and responsibilities:

Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, the responsibilities of this position are:

• Ensure compliance with EU and local legislation, Regulatory Authority requirements and applicable standards, establishing compliant approaches and driving timely action across relevant functions.
• Act as a contact person for the local Competent Authorities for Medical Devices and independently coordinate clear, accurate and timely responses to regulatory agencies' questions, requests and other correspondence when the Technical Responsible is unavailable.
• Ensure that all medical devices comply with local legislation before being placed on the market, escalating material risks and recommending mitigation where required.
• Provide regulatory guidance for promotional and non-promotional materials through the local copy review process, ensuring compliance with applicable laws, regulations, industry codes, and internal Johnson & Johnson policies and procedures.
• Ensure that all promotional materials comply with EU regulations and applicable local legislation and requirements.
• Lead the local regulatory review of Instructions for Use, labelling information for marketed products, letters, notifications and promotional materials, when requested by the Manufacturer or Authorised Representative, ensuring accurate local-language translation and full compliance with local requirements.
• Serve as an RA partner to the Tender and Marketing departments, providing informed authoritative regulatory input on product technical characteristics and ensuring current documentation is available to support business and customer needs.
• Establish and maintain local Regulatory document database.
• Lead the planning, preparation and submission of detailed regulatory information required for submissions notifications and questions for new and existing products to meet applicable requirements and business timelines.
• Notify all class IIa, IIb and III medical devices in AEMPS database when they are made available on the Spanish market, resolving issues and ensuring completion within required timelines.
• Interpret existing, new and changing national regulatory requirements and provide clear, actionable guidance to J&J businesses, independently evaluating impact.
• Supervise import activities to support the clearance process during health inspections at customs and independently authorise the release of imported lots after verifying compliance with local legislation, when the Technical Responsible is unavailable.
• Provide the necessary regulatory assessment and support to lift the restrictions that occur in the systems (between MDRIM and RAD), coordinating stakeholders and driving issues to timely closure.
• Act as the accountable RA partner responsible for CIGNON approvals supporting the CIGNON system for new product launches.
• Maintain MDRIM system in accordance with the end-to-end strategy processes.
• Represent Regulatory Affairs on cross-functional project teams, contribute to compliant policies and operational plans, and coach junior colleagues and partners on regulatory techniques, processes and responsibilities.
• Additional specific responsibilities may also be detailed in the Quality Management System.

Essential Requirements:

• University Degree in healthcare area (pharmacy or medicine)
• Demonstrable experience and knowledge in medical device regulatory requirements, compliance, quality systems, importation or distribution activities and commercialisation.
• 4-6 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
• Good knowledge of medical device regulatory requirements in the EU
• Strong collaboration skills and ability to build partnerships internally and externally
• Ability to work effectively in a highly matrixed organization
• Strong results-orientation and sense of urgency
• Excellent written and oral communication skills in Spanish and English

Required Skills:

Graduate Medical Education (GME), Regulatory Affairs Compliance

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is:

€55,400.00 - €87,860.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.