Senior Regulatory Affairs Manager

Job Title

Job Description

Senior Regulatory Affairs Manager

The Senior Regulatory Affairs Manager ensures all products meet regulatory standards by coordinating submissions, managing compliance, and providing strategic guidance to development teams. This role also monitors regulatory changes, oversees documentation, and manages cross-functional collaboration and talent within the team.

Your role:

• Align regulatory strategies with business goals to integrate requirements into product development and improve productivity. 
• Communicate clearly with teams and regulatory agencies, ensuring transparency and a proactive approach in regulatory activities. 
• Drive continuous improvement through strategic partnerships and implement automation to boost efficiency. 
• Evaluate the organization’s Regulatory Excellence maturity to identify areas for enhancement and guide strategic initiatives. 
• Develop and update regulatory policies to ensure compliance across all business units and assess new guidelines for necessary adjustments. 

You're the right fit if:

• You’ve acquired 8+ years of experience with Bachelor's or 6+ years of experience with Master's in areas such as Regulatory Affairs, Quality Compliance, Product Development in the Medical Devices Industry or equivalent. You are an experienced people leader in the medical devices regulatory affairs space with extensive experience with international submissions (LATAM, Japan, China, South Korea, etc.).   
• You have a bachelor's Degree/master’s degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. RAPS RAC preferred.
• Advanced English Level

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-based 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.

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 be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

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