Director of Regulation

We are seeking a Director of Regulation to join our fast-growing startup in the health and technology sector. This role requires strategic expertise navigating regulatory frameworks across B2B, B2C, and B2B2C models. The Director of Regulation will ensure compliance, manage risk, and drive the development of policies that align with industry standards and business objectives. 

Key Responsibilities: 

• Develop and implement regulatory strategies that support compliance across B2B, B2C, and B2B2C models. 

• Manage QA System with R&D 

• Monitor and ensure adherence to local, national, and international regulations, adapting strategies as laws evolve. 

• Collaborate with internal teams to align operations with regulatory requirements, minimizing risk and optimizing processes. 

• Oversee the preparation and submission of regulatory filings and reports, ensuring accuracy and timeliness. 

• Serve as the primary point of contact with regulatory authorities and industry bodies. 

• Identify and address regulatory risks, creating policies and practices to mitigate them. 

• Train and guide teams on compliance protocols, fostering a culture of regulatory excellence. 

• Stay informed on emerging regulations and trends, ensuring the company remains proactive and competitive. 

Requirements: 

• Proven experience in regulatory affairs, compliance, or a related field, preferably in the health or technology sectors. 

• Experience working with Regulatory authorities such as the FDA, EMA HC, TGA, MFDS, ANVISA, IMOH, etc, and be able to handle and link between the product at its different manufacturing stages and the global regulatory bodies. 

• Strong knowledge of local and international regulatory requirements and frameworks. 

• Expertise in risk management, policy development, and compliance monitoring. 

• Experience registering digital solutions under FDA, CES, AMAR, etc 

• Excellent communication skills for cross-departmental collaboration and regulatory interactions. 

• Ability to work in dynamic, fast-paced environments with a focus on innovation and adaptability. 

• Proficiency in English, with a strong ability to convey complex regulatory concepts clearly. 

• Availability to attend in-office meetings in Barcelona every two weeks.

Competencies: 

• Strategic Regulatory Leadership: Ability to craft and execute compliance strategies that align with business goals. 

• Risk Management: Proactively identify, assess, and address regulatory risks. 

• Collaboration: Work effectively with cross-functional teams and external stakeholders. 

• Adaptability: Navigate evolving regulations and implement forward-thinking solutions. 

• Attention to Detail: Ensure accuracy and thoroughness in compliance monitoring and reporting.