Senior Regulatory Affairs Specialist

Primary Function of Position:

The Senior Regulatory Affairs Specialist plays an important role within the Regulatory Affairs Department, focusing on providing advanced regulatory support for New Product Development (NPD) and sustaining operations across designated Business Units. This position requires a deep understanding of EU and global medical device regulations, and significant experience in managing regulatory submissions and compliance activities. The Senior Regulatory Affairs Specialist collaborates with cross-functional teams, offering expert guidance on regulatory matters, while contributing to the success of product launches and ongoing operations.

Roles and Responsibilities:

Main activities

• Lead regulatory efforts in NPD projects and sustaining operations for Business Units, including preparing, coordinating, and maintaining EU Medical Device dossiers, CE Mark submissions, and associated Technical Documentation, ensuring compliance with EU regulations.
• Act as a lead contact for Notified Bodies, representing the company’s regulatory strategies, addressing inquiries, and ensuring compliance with applicable regulations.
• Manage the preparation, submission, and maintenance of EU Medical Device and geographic-specific registration dossiers, ensuring alignment with business objectives, timely regulatory approvals, and up-to-date records.
• Collaborate in the development and implementation of EU regulatory strategies for new product introductions, product changes, and new indications, ensuring alignment with business goals.
• Provide regulatory advice to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements.
• Monitor and communicate changes in Global and EU medical device regulations and standards, updating company policies and procedures as necessary to maintain compliance.
• Coordinate registration strategy with Sales and Marketing stakeholders, aligning regulatory requirements with business objectives.
• Lead or participate in process improvement initiatives aimed at enhancing regulatory submission efficiency and effectiveness within the Regulatory Affairs Department.

Additional activities

• Assist in maintaining and enhancing the Quality Management System (QMS), including CAPA, Management Review, and participation in internal/external audits and inspections, ensuring compliance with ISO 13485 and other regulatory requirements.
• Mentor and guide junior regulatory team members, contributing significantly to their development and the continuous improvement of the Regulatory Affairs department.
• Provide regulatory support to other departments, including R&D, engineering, and clinical affairs, contributing to successful product development and lifecycle management.
• Respond to regulatory inquiries from key stakeholders, including Customer Service, Contract/Tender, and Sales departments, providing timely and accurate information.
• Perform other regulatory tasks and projects as assigned, ensuring regulatory compliance across various markets and regions.

Required Knowledge, Skills, and Experience:

• A minimum of 8+ years of experience in regulatory affairs within the medical device industry, with significant experience in EU regulations.
• A Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly preferred, though practical experience in a similar role will be considered.
• In-depth understanding of Global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).
• Proven experience leading EU submissions for NPD projects and sustaining activities, including preparing CE Mark documentation and managing interactions with Notified Bodies.
• Strong organizational, leadership, and interpersonal skills, with a proactive approach to problem-solving, a sense of urgency, and the ability to collaborate effectively within international teams and across departments.
• A meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
• Knowledge of EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive.
• Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms.
• General computer proficiency, including Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook.

Preferred Knowledge, Skills, and Experience:

• Exposure to Class III medical device submissions under the EU Medical Device Regulation, particularly for CE Marking, is desirable.
• Experience in project management or leading cross-functional teams in regulatory affairs or product development contexts.
• Familiarity with US FDA regulations (21 CFR 820.30) and experience with 510(k) submissions is an advantage.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.