Descripción de la oferta
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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