Regulatory Affairs Specialist


Minneapolis, MN, USA Remote

Full time


Sep 14

Regulatory Affairs Specialist

Job Description

As a core member of multiple sustaining and new product development teams, the Sr Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) mostly independently with periodical supervisor’s support by owning the following tasks:

Your role:

  • Lead a team within Regulatory or Cross Functional Team to set and deliver the objectives
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required
  • Communicate with regulatory agencies as needed
  • Ensure standard and process compliance.
  • Provide audit, CAPA and post market regulatory support
  • Mentor other regulatory affairs personnel within HPM Regulatory

You're the right fit if:

  • Bachelor’s degree required in a technical discipline.
  • Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
  • RAPs RAC strongly preferred.
  • ASQ certifications also desirable.
  • Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II or class III, etc.).
  • Proficient knowledge of medical device regulations minimum FDA and Canada, Worldwide is desired. Must have personal experience with successful preparation and submission of 510(k) submissions.
  • Able to work effectively with minimal supervision
  • Proficient knowledge of domestic and international standards
  • Strong background in Design Controls.
  • Experience in supporting international registrations and/or clinical investigations.
  • Experience with Software Medical Devices strongly preferred.
  • Proficient computer skills in Microsoft Office Suite
  • Understand LEAN concepts, methodologies and deployment.
  • May require 5% travel annually with possibly some international.
  • 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.

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.
  • Read more about our employee benefits.

If you’re 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 commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $74,000 to $136,000, annually. The actual base pay offered may vary 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.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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