Purpose of the Position

The Director of Regulatory Affairs ensures that the company’s products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical devices, and ensuring timely updates for existing products. The ideal candidate will have deep expertise in drug regulations and approvals, working within a global team to interpret regulatory changes and advise internal stakeholders accordingly. The role also includes strategic oversight of regulatory submissions, coordination with authorities, and maintaining compliance with evolving guidelines.

Key Responsibilities

General Regulatory Responsibilities

• Develop and execute regulatory strategies aligned with business goals.

• Prepare regulatory submissions to obtain and maintain market clearance in the EU and North America.

• Serve as a liaison with national regulatory authorities in the EU and North America.

• Support regulatory submissions for additional global markets as required.

• Maintain an up-to-date knowledge base of regulations, standards, and guidance documents.

• Ensure company and product listings are maintained in regulatory authority databases.

• Perform regulatory reviews and approvals of change requests.

• Review promotional material and relevant press releases for compliance.

• Participate in post-market vigilance activities and coordinate post-market surveillance efforts.

Regulatory Support for Development Projects

• Provide regulatory guidance for development projects, interpreting applicable regulations and standards.

• Work cross-functionally to establish product claims, complaints, intended use, and safety documentation to support regulatory clearance.

• Collaborate with Technical Development and Clinical Development to ensure product safety and efficacy align with clinical evidence.

• Partner with Commercial Operations and Technical Development for instructions for use (IFU) and labeling.

• Support external verification testing of equipment, disposables, and software when necessary.

• Establish, review, and approve regulatory documentation and registration dossiers for submission.

• Develop and review controlled documents, including General Safety and Performance Requirements (GSPR) checklists, declarations of conformity, and intended use documentation.

Quality Assurance & Regulatory Compliance (QA/QMS)

• Support internal and external audits.

• Conduct regulatory assessments of supplier competencies and review supplier quality agreements.

• Provide regulatory strategies to define QMS requirements for medical device and drug/medicinal production.

• Establish and maintain regulatory processes within the Quality Management System (QMS).

Key Relationships

Internal:

• Research & Development, Clinical Research, Quality Assurance, Medical Affairs, Operations

External:

• Regulatory authorities, Investigator sites supporting regulatory document submissions

Skills & Experience

Must-Haves:

• Bachelor’s degree in life sciences or a related field.

• 10+ years of experience in pharmaceutical drug development.

• Recent experience in NDA submissions.

• Strong working knowledge of Good Clinical Practice (GCP) and relevant international standards.

Nice to Have:

• Experience in nuclear medicine.

• Background in diagnostics.

• Advanced degree (MSc, PhD, or equivalent).

• Experience in regulatory support for combination product development.

• Project management experience.

Can Be Trained:

• Nuclear medicine science.

• Knowledge of ISO 13485 and MDSAP.

• Understanding of IEC 60601-1 series and ISO 62304.