Regulatory Affairs Specialist

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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 the 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 Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• Minimum required Experience: Minimum 2 years of experience with a Bachelor’s degree in areas such as Regulatory Affairs, Quality Compliance, Product Development in the Medical Devices Industry, or equivalent OR no prior experience required with a Master’s Degree.

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.