Sr Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist will support regulatory strategies and submissions for Robotics Surgery technologies in global markets. This role contributes to new product development, sustaining, and lifecycle management activities for Class II medical devices that include hardware and software components.

Responsibilities

• Supports design changes, labeling updates, product modifications, and other lifecycle management activities to ensure ongoing regulatory compliance.
• Documents regulatory decisions, prepares, and supports agency submissions.
• Assesses regulatory impact of product and process changes, reviews promotional materials, and ensures product technical documentation remains current, accurate, and aligned with applicable regulatory requirements.
• Collaborates with cross-functional partners across the business unit, including Regulatory Affairs, Research and Development, Clinical, Quality, Manufacturing, and Marketing.
• Keeps senior management informed of product regulatory status and significant regulatory issues.

Requirements

• Minimum Requirements: Bachelor’s degree required, minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
• Nice to Have: Advanced degree in regulatory affairs, biomedical engineering, life sciences, or related field; RAC certification or progress toward RAC certification; experience supporting Class II and Class III medical devices; working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and other international markets; experience preparing or supporting 510(k), PMA, Technical Documentation, or international submissions; familiarity with design controls, risk management, and usability engineering; understanding of software-enabled devices, cybersecurity, or AI-enabled products, if relevant to the portfolio; experience working with cross-functional teams including R&D, quality, clinical, marketing, and manufacturing; knowledge of applicable standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304; strong technical writing, document review, and submission authoring skills; experience interacting with regulatory authorities, notified bodies, or internal auditors; project management skills with ability to manage multiple priorities and deadlines; strong communication and influence skills in a matrixed organization; experience with surgical, capital, or robotic medical devices.

Qualifications

• Minimum Requirements: Bachelor’s degree required, minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
• Nice to Have: Advanced degree in regulatory affairs, biomedical engineering, life sciences, or related field; RAC certification or progress toward RAC certification; experience supporting Class II and Class III medical devices; working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and other international markets; experience preparing or supporting 510(k), PMA, Technical Documentation, or international submissions; familiarity with design controls, risk management, and usability engineering; understanding of software-enabled devices, cybersecurity, or AI-enabled products, if relevant to the portfolio; experience working with cross-functional teams including R&D, quality, clinical, marketing, and manufacturing; knowledge of applicable standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304; strong technical writing, document review, and submission authoring skills; experience interacting with regulatory authorities, notified bodies, or internal auditors; project management skills with ability to manage multiple priorities and deadlines; strong communication and influence skills in a matrixed organization; experience with surgical, capital, or robotic medical devices.

Skills

• Advanced degree in regulatory affairs, biomedical engineering, life sciences, or related field.
• RAC certification or progress toward RAC certification.
• Experience supporting Class II and Class III medical devices.
• Familiarity with global regulatory requirements, including FDA, EU MDR, Health Canada, and other international markets.
• Experience preparing or supporting 510(k), PMA, Technical Documentation, or international submissions.
• Familiarity with design controls, risk management, and usability engineering.
• Understanding of software-enabled devices, cybersecurity, or AI-enabled products, if relevant to the portfolio.
• Experience working with cross-functional teams including R&D, quality, clinical, marketing, and manufacturing.
• Knowledge of applicable standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
• Strong technical writing, document review, and submission authoring skills.
• Experience interacting with regulatory authorities, notified bodies, or internal auditors.
• Project management skills with ability to manage multiple priorities and deadlines.
• Strong communication and influence skills in a matrixed organization.
• Experience with surgical, capital, or robotic medical devices.

Benefits

• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).

Pay

$92,000.00 - $138,000.00 USD

Schedule

Full-time