Regulatory Affairs Program Manager

Job Title

Job Description

Regulatory Affairs Program Manager

In this role you

The Regulatory Affairs Program Manager is responsible to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely tracking of regulatory activities, leading regulatory excellence and continuous improvement projects and programs. The role serves as a key liaison with external and internal stakeholders and undertakes comprehensive evaluations of the organization to assess its current level of regulatory excellence maturity, identifying strengths, weaknesses, and opportunities for improvement.

Your role:

• Leads regulatory compliance in partnership with business unit affairs and other cross-functional partners in the areas of refurbishment, supply chain, and life cycle management activities.
• Maintains key regulatory policies and guidances for the enterprise related to lifecycle management, refurbishment, remanufacturing, and supply chain.
• Utilizes project and program management skills to lead projects focused on regulatory compliance and process improvement to enhance performance and drive organizational change.
• Leads and supports validation of Regulatory Affairs IT platforms, performing the roles of tester, business process expert, and creating the deliverables.
• Represents Regulatory Affairs Centralized Services in regulatory audits and certification meetings, participates in resolving audit findings, and ensures the appropriate deployment of Regulatory Affairs related processes and documents across the QMS.

You're the right fit if:

• Bachelor's Degree in Business Administration, Legal, Communications, Science or equivalent. Masters degree preferred.  RAPS RAC, CAPM, Six Sigma, CCMP certifications desired.

• 5+ years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Project Management, Continuous Improvement or equivalent.
• Preferred experience: One or more years of experience with validation of software tools,  leading regulatory compliance within the service, refurbishment, and supply chain domains, using regulatory information management (RIM) tools, and UDI machine to machine software.

• 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 culture.

Philips Transparency Details

The pay range for this position in Cambridge, MA is $137,000 to $190,000 Annually. 

The pay range for this position in Plymouth, MN is $127,500 to $178,500 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 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. 

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. 

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Plymouth MN or Cambridge MA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.