NL-QR

Regulatory Affairs Business Specialist

Job Profile Summary
The Regulatory Affairs Business Specialist 60 is responsible for recommending 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. The role converts Regulatory knowledge into viable options of solutions with moderate scope/complexity, demonstrating basic regulatory affairs knowledge in multiple areas - different submission types, awareness of geography regulations and pre/post market requirements, possessing solid understanding with regards to sources of regulatory information. The role works under general supervision on larger, moderately complex project/assignments, contributing to complex strategies and making informed decisions after consultation from supervisor or senior members. The role supports internal/external audits and inspections as needed, acting as an informal resource to guide and mentor junior resources in the team, and performs Change Management activities including hosting of meetings to acquire change details for sustaining products, notifying geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance.

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 Qualifications
Education
Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
Work Experience
Minimum 2 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR no prior experience required with Master's Degree


Preferred Qualifications
Certifications 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