Senior Regulatory Affair Specialist

Job Title

Senior Regulatory Affair Specialist

Job Description

Sr. Regulatory Affairs Specialist

In this role you

The Senior Regulatory Affairs Specialist plays a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards. This position reports to the Head of Regulatory Affairs for IGTD-CV.

Your Role

• Advise internal stakeholders (R&D, Marketing, Manufacturing, etc.) regarding laws, regulations, and guidance as they relate to the CV products portfolio to ensure regulatory inputs and outputs are in alignment with regulatory authority expectations and company objectives.
• Develop and implement global regulatory strategies, including submission risk mitigations, through deep understanding of the product’s technical characteristics and regulatory landscape.
• Achieve successful device clearances/approvals for the US, Canada, EU and support licenses/registrations of devices worldwide through creative problem solving and high-quality submissions.
• Present to and communicate with internal stakeholders and regulatory agencies, as needed.
• Provide support as it relates to medical device submissions and certifications during product surveillance and QMS audits, as needed.
• This Hybrid-based role may require travel up to 10%.
  
  

You're The Right Fit If

• 5 years Regulatory Affairs experience within regulated medical device/technology environments, including regulatory submissions (e.g., US FDA 510(k), PMA, IDE, Q-Subs, EU MDR Technical Document) in an area relevant to cardiovascular, imaging, sterile disposable, and/or hardware/software devices. Experience with Software Function (MDSW) and Artificial Intelligence/Machine Learning is a plus.
• Demonstrated a Sr-level of Regulatory Domain knowledge and expertise by leading others (e.g., product development core team) in global regulatory matters of diverse product categories.
• A bachelor’s degree (master’s degree desired), preferably in Regulatory Affairs and/or a science or engineering-related field. RAPS RAC credential is a plus.
• Strong written, oral, and interpersonal skills to effectively compose agency submissions and collaborate cross-functionally. Experience in the use of MS Office and Adobe Acrobat. Knowledge of PLM software, such as Windchill is a plus.
• 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 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 San Diego, CA is $82,000 – 150,000, Annually.

The pay range for this position in Plymouth, MN is $82,000 – 140,000, Annually.

The pay range for this position in Colorado Springs, CO is $82,000 – 140,000, 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 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 San Diego, CA, Plymouth MN, Colorado Springs, CO.

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.