Sr. Regulatory Affairs Specialist

This role involves implementing global regulatory strategies, ensuring compliance with company policies and regulatory requirements, and managing safety risks. The specialist will collaborate with cross-functional teams, coordinate witness testing, and take ownership of regulatory planning for new products. Key tasks include developing regulatory submissions, creating marketing and labeling materials, and recommending process enhancements to maintain regulatory compliance throughout the product lifecycle.

Must Have

• Implement global regulatory strategies and roadmaps
• Exercise independent judgment on matters of significance
• Understand regulator's role in the Quality System
• Lead comprehensive safety risk assessments
• Manage safety incidents in Trackwise
• Monitor potential regulatory impacts on product safety
• Collaborate with central and regional Regulatory Affairs teams for establishment registration and UDI/GTIN activities
• Coordinate and facilitate witness testing for safety regulations compliance
• Maintain direct contact with certification bodies, test houses, and regulatory personnel
• Take ownership of regulatory planning for new product introductions and changes
• Support maintenance of regulatory compliance throughout the product lifecycle
• Develop and facilitate regulatory submissions for new and existing products/solutions
• Create, review, and validate marketing and labeling materials
• Implement safety and compliance requirements for product development projects and OEM/ODM products
• Administer compliance protocol process within PDLM and MLD
• Minimum of 10-12 years of experience in medical device regulated environment
• Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
• Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
• Excellent verbal and written communication skills (English)

Good to Have

• Knowledge of NMPA requirements
• Experience in supporting international registrations (OUS and Outside EU)
• Experience in clinical investigations
• RAPS RAC certification
• Regulatory Requirements
• Document Auditing
• Data Management
• Regulatory Reporting
• Product Registrations
• Product Labeling
• Strategy Implementation
• Stakeholder Management
• Regulatory Submission Documentation
• Conformity Assessment
• Regulatory Intelligence
• Regulatory Compliance
• Risk Mitigation Strategies
• Continuous Improvement
• Project Management

Perks & Benefits

• Hybrid work concept fusing flexibility with collaboration
• Workspaces designed to support well-being
• Offer career advancement opportunities
• Commitment to inclusion and diversity
• Equal opportunities for all employees and applicants
• Meaningful work focused on innovative, customer-first health technology solutions

Job Responsibilities:

• Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives.
• Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability.
• Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented.
• Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations.
• Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle.
• Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product registrations such as CE Marking and clinical evaluations.
• Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions.
• Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards.
• Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates.
• Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies.
• Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards.

Minimum required Education:

Bachelor's/Master's degree in a software, technical, or biomedical discipline

Minimum required Experience:

• Minimum of 10-12 years of experience in medical device regulated environment - Mandatory
• Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
• Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
• Excellent verbal and written communication skills (English)
• Enthusiastic, self-motivated regulatory professional
• Good communicator and team player who is able to work in a flexible and goal-oriented environment
• Structured way of working
• Problem solving and time management skills

Preferred Experience:

Knowledge of the NMPA requirements. (preference)

Experience in supporting international registrations (OUS and Outside EU) and clinical investigations

Preferred Certification:

RAPS RAC certification

Preferred Skills:

• Regulatory Requirements

• Document Auditing

• Data Management

• Regulatory Reporting

• Product Registrations

• Product Labeling

• Strategy Implementation

• Stakeholder Management

• Regulatory Submission Documentation

• Conformity Assessment

• Regulatory Intelligence

• Regulatory Compliance

• Risk Mitigation Strategies

• Continuous Improvement

• Project Management