Job Title:  Senior Regulatory Specialist

As a Senior Regulatory Specialist, you play a crucial role in ensuring that safe and effective products are available in Reichert’s desired markets. Your experience with medical devices (Class I, II Active Device), project management, communication, judgment, and ability to learn from others are key assets for this position.

The Senior Regulatory Specialist will:

• Participate in compliance, customer, third-party regulatory, and vendor audits. Conduct internal audits of the Quality Management System as necessary.
• Prepare and submit applications for product approval/registration for global markets. Address questions, negotiate solutions, and ensure continuation or re-registration in desired markets. This includes updating device labeling, managing document translations, refining company processes, and interfacing with distributors, regulatory bodies, and consultants.
• Collaborate effectively with complex teams and foreign companies, considering cultural differences. Read, analyze, and interpret common scientific, technical journals, and legal documents.
• Ensure compliance with EU MDR requirements by preparing the necessary technical documentation.
• Participate in product development project teams, providing advice and direction on registration requirements. Determine new product regulatory classifications and define specifications to ensure products align with company goals and maximize successful market launches.
• Review and approve test reports, clinical evaluations, and similar documentation to support device compliance and registrations.
• Work with third-party laboratories and accrediting bodies in product development and maintenance.
• Collaborate with operations personnel to ensure ongoing compliance with quality system requirements.
• Work with cross-functional teams to perform Risk Management activities and maintain the Risk Management File.
• Maintain knowledgeable, collaborative, and effective interactions with Production, Research & Development, Product Management, and Engineering teams to advance the QMS and communicate it to external bodies.
• Ensure device labeling, including marking, packaging, user documentation, and marketing communications, complies with relevant regulations and norms.
• Validate and assess engineering changes for risk as required by regulation, ensuring contractual and safety obligations to affected parties and approving bodies are addressed before implementation.
• Assist Sales in preparing regulatory documentation for international dealers, including determining local statutes and defining contractual requirements. Produce regulatory documentation as needed to authorize international dealers for global sales, including generating CoA/CoC documentation and customer-required documents.
• Engage in post-market activities related to reporting, vigilance, product recalls, etc.
• Engage in self-directed continued education and training in current and evolving regulations.

Senior Regulatory Specialist Position Requirements:

• Bachelor’s degree in engineering or a related field; advanced degree preferred.
• Minimum of 10 years of experience in engineering leadership roles, preferably within the electronic instruments or electromechanical devices industry.
• Demonstrated success in leading product development initiatives.
• Strong technical background and understanding of engineering principles and practices.
• Excellent leadership, communication, and interpersonal skills.
• Ability to think strategically and execute tactically.
• Experience with project management and budget oversight.
• Proficiency with digital tools and digital literacy.
• Ability to make decisions based on data.
• Commitment to sustainability.
• Ability to innovate and think creatively.
• Ability to adapt and be agile in a dynamic environment.
• Strong collaboration and teamwork skills.
• Commitment to fostering a diverse and inclusive work environment.