15h Left Regulatory Affairs Program Manager

Job Description

Job Description

The Regulatory Affairs Program Manager will be responsible for

- Providing Regulatory Technical Competency (tactical and strategic) to the AM&D business group, including providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams and preparing comprehensive regulatory strategies for new devices and significant post market changes.
- Assess product changes for impact on global regulatory registrations, ensuring continued compliance with applicable regulations.
- Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales.
- Develop and prepare product registration submissions for the US, Canada, EU, and support submission preparation for additional regulated markets.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Keep abreast of current regulatory standards, procedures and changes.
- Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations and drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance

Additionally, the Regulatory Affairs Program Manager will:

- Communicate effectively with internal stakeholders
- Collaborate with worldwide colleagues regarding license renewals and updates
- Maintain regulatory files and tracking databases as required
- Support the audit team as subject matter expert.
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To succeed in this role, you should have the following skills and experience

- Bacheloru2019s degree (Masteru2019s/PhD preferred) preferably in Regulatory Affairs, Engineering and/or a science related field or equivalent experience in the medical device industry.
- 8+ years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.).
- Knowledge of regulations applicable to software, including software as a medical device (SaMD) and software in a medical device (SaMD).
- Strong background in Design Controls.
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws, regulations and standards including ISO 13485, ISO 14971, IEC 60601-1 and related particular standards.
- Personal experience with successful preparation and submission of US 510(k) and/or PMA submissions, EU MDR submissions, and global registration dossiers strongly preferred.
- Experience in supporting clinical investigations.
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require 10% travel annually with possibly some international.

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.
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.
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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 .