Regulatory Affairs Specialist

Job Description

Job Title : Regulatory Affairs Specialist

Job Responsibilities:
u2022 Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
u2022 Works under general supervision within established processes and operational policies, exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.
u2022 Demonstrates basic understanding of regulatory's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
u2022 Applies analytical skills to resolve less complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
u2022 Fosters productive internal and external working relationships to resolve mutual problems by conveying information, contributing to streamlined operations and improved outcomes, primarily communicating with internal contacts within the immediate group.
u2022 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.
u2022 Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
u2022 Works within standardized procedures and practices to achieve objectives and meet deadlines, making decisions that have limited impact on own work team and minimal impact on business, shadowing senior specialists on sustaining and NPI project Core teams.
u2022 Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related change control processes, supporting the Marketing Teams on Tender related issues.
u2022 Participates in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the Business and Field levels.
u2022 Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.
u2022 Supports the dissemination of specific regulatory requirements and memos applicable to relevant sites, advising cross-functional teams on regulatory standards and facilitating smooth business operations and market access.
u2022 Participates in evaluating the adequacy of information provided in development quality reports and plans to support submissions, ensuring products comply with regulatory standards and regulations.

Minimum required Education:
Bachelor's Degree in Biomedical Engineering, Health Sciences, Pharmaceutical

Minimum required Experience:
Bachelor's Degree with minimum 5-6 years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.

Preferred Certification:
RAPS RAC certification

Preferred Skills:
u2022 Regulatory Requirements
u2022 Document Auditing
u2022 Data Management
u2022 Administrative Support
u2022 Product Registrations
u2022 Product Labeling
u2022 Strategy Implementation
u2022 Stakeholder Management
u2022 Regulatory Submission Documentation
u2022 Conformity Assessment
u2022 Regulatory Intelligence
u2022 Continuous Improvement

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .