Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

Job title:
Regulatory Affairs Specialist

Your role:

• 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 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.

• 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

You're the right fit if: (4 x bullets max)
1. Experience- 5+ years of experience in Regulatory submission (Must have medical device experience), Pharma application will not consider
2. Skills- US FDA, EUMDR Submission, 510K, Dossier Preparation and submission
3. Education- BE in any engineering
4. Anything else.

• 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

• RAPS RAC certification

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 company’s facilities.
Field roles are most effectively done outside of the company’s 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 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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re 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.

Experience Level

Mid Level