We are seeking an experienced Regulatory Affairs Director to lead the regulatory strategy and compliance for our Spanish biopharma company. This role will oversee a team of RA professionals, provide guidance to senior leadership, and ensure global regulatory compliance for medical devices and related products.
Key Responsibilities:
* Lead regulatory strategy for assigned projects, ensuring alignment with business objectives and compliance with local and international regulations.
* Advise senior leadership on regulatory risks, strategy, and mitigation plans.
* Monitor regulatory changes that may impact business and product strategy.
* Manage, mentor, and develop RA team members, including performance reviews and resource allocation.
* Oversee regulatory submissions, approvals, and compliance activities, including post-market obligations.
* Act as the Person Responsible for Regulatory Compliance (PRRC), ensuring conformity with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
* Collaborate with cross-functional teams (R&D, Quality, Marketing, Product Engineering) and external stakeholders (regulatory authorities, distributors, registration agents).
* Participate in audits and ensure RA department adherence to quality system requirements.
Qualifications:
* Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
* 10–15 years of medical device or biopharma regulatory experience, with at least 5 years in a leadership role.
* Strong knowledge of EU and international regulatory requirements for medical devices, software, and related products.
* Proven experience developing regulatory strategies, securing approvals, and managing complex product portfolios.
* Experience in line and matrix management; strong leadership and mentoring skills.
* Excellent communication, organizational, and problem-solving abilities.
* Ability to work in a fast-paced environment and manage multiple priorities.
* Travel within Spain and internationally as needed.
What We Offer:
* Competitive total compensation package.
* Comprehensive benefits, including health coverage, retirement plans, paid time off, and professional development opportunities.
* Collaborative and innovative work environment.
Equal Opportunity Statement:
We are committed to diversity and inclusion and provide equal employment opportunities to all qualified applicants regardless of race, gender, age, disability, or other protected status.
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