Associated Regulatory Affairs Manager

Job Title

Job Description

Job Responsibilities:
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.
Works under general supervision within established processes and operational policies exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.
Demonstrates basic understanding of regulatorys 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.
Applies analytical skills to resolve less complexity requests efficiently exercising judgment within defined procedures/practices to determine appropriate action.
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.
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.
Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions ensuring alignment with regulatory requirements and standards.
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.
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.
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.
Keeps abreast of regulatory procedures and changes participates in process improvement activities related to internal regulatory processes as well as evolving Regulatory Agency changes.
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.
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:
Bachelors Degree / Vocational Education in Biomedical Engineering Business Administration Health Sciences Pharmaceutical Law or equivalent.

Minimum required Experience:
No prior experience required with Bachelors Degree OR minimum 4 years of experience with Vocational Education in Regulatory Affairs Quality Compliance Product Development in Medical Devices Industry or equivalent.

Preferred Certification:
RAPS RAC certification

Preferred Skills:
Regulatory Requirements
Document Auditing
Data Management
Administrative Support
Product Registrations
Product Labeling
Strategy Implementation
Stakeholder Management
Regulatory Submission Documentation
Conformity Assessment
Regulatory Intelligence
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 companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre 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 here.