Senior Regulatory Affairs Specialist

Job Title

Senior Regulatory Affairs Specialist

Job Description

Sr. Regulatory Affairs Specialist

In this role you

The Senior Regulatory Specialist will provide regulatory support for our Image Guided Therapy business including direct submission to health authorities and indirect project management of worldwide registrations. You will execute regulatory strategy to support the growth within the Structural Heart/Heart Rhythm Management category

Your role:

• Preparing comprehensive regulatory strategies for potentially complex new devices, and significant post market changes (such as line extensions, indication expansions, and substantive process/design changes). As necessary, reviews complex regulatory strategy issues with RA management.
• Preparing regulatory filings for the US, EU, and Canada, potentially including FDA Pre-Submissions (and similar) for new products, as well as post-market changes. Maintain proficiency in worldwide regulatory requirements, particularly within US, EU, Canada, Japan, and China.
• Following Philips' Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
• Able to professionally negotiate and lead meetings (eg Pre-Subs) directly with regulatory agencies (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg Chief or Deputy) level. 

You're the right fit if:

• Minimum of a bachelor’s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred.
• Minimum of 5+ years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience. Prefer 2+ years of experience with SaMD.
• Proficiency in understanding, interpretation and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
• Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentation and global registrations
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. 

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.

This is an office 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 improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in Plymouth is $75,000 to $130,000, Annually. 

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.    

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may b