Director of Regulatory Affairs

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.