Sr Regulatory Affairs Specialist

Medtronic•Boston, MA

6d•$92,000 - $138,000

About The Position

The Senior Regulatory Affairs Specialist will play a key role in supporting regulatory strategies and submissions for Robotics Surgery technologies in global markets. This role will contribute to new product development, as well as sustaining and lifecycle management activities for Class II medical devices that include hardware and software components. The Senior Regulatory Affairs Specialist will work closely with new product development and cross functional sustaining teams to help define global regulatory strategy and support regulatory activities throughout the product lifecycle, from concept and development through commercialization, post-market support, and product changes. This individual has primary responsibility for supporting compliance with U.S. and EU regulatory requirements and will partner with international regulatory affairs colleagues to support worldwide submissions for Class II medical devices. Responsibilities include supporting design changes, labeling updates, product modifications, and other lifecycle management activities to ensure ongoing regulatory compliance. Additional responsibilities include documenting regulatory decisions, preparing and supporting agency submissions, assessing regulatory impact of product and process changes, reviewing promotional materials, and ensuring product technical documentation remains current, accurate, and aligned with applicable regulatory requirements. This work is performed through collaboration with cross-functional partners across the business unit, including Regulatory Affairs, Research and Development, Clinical, Quality, Manufacturing, and Marketing. Additional responsibilities include keeping senior management informed of product regulatory status and significant regulatory issues, while maintaining strong knowledge of global regulatory requirements. The successful candidate will be comfortable working with advanced concepts and ambiguity, able to operate independently, develop creative regulatory strategies, and collaborate effectively within Regulatory Affairs and across other business functions.

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 Haves

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
Experience with regulatory impact assessments for design changes, labeling updates, and product lifecycle management
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.

Responsibilities

Provides regulatory strategy, submission support, and compliance oversight for surgical robotics medical devices across the product lifecycle.
Recommends changes for labeling, manufacturing, software, cybersecurity, marketing, and design of medical devices for regulatory compliance.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.