Job Title
Principal Regulatory Affairs Specialist-Ultrasound
Job Description
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies and post market changes for complex, new/existing Ultrasound systems/devices.
Your role: Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management.
Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.
Will mentor/coach Philips regulatory professionals; drive improvement in regulatory aspects of the Quality Management System, in developing/documenting processes and procedures to maintain an effective Quality System.
Lead communication/negotiation with regulatory entities on regulatory filings at the reviewer level.
Provide guidance on global compliance such as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485, and ISO 14155, China NMPA, Canada, Japan JPAL, compliance with FDA's guidance documents, requirements and procedures when new regulatory requirements are determined to go into effect.
Represents Philips in internal/external audits with regulatory agencies or Notified Bodies.
Provide regulatory support for (pre) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
Reporting to the Director of Regulatory Affairs-Ultrasound, you will partner with regulatory Affairs team members globally, Engineering, R&D, Manufacturing and other cross-functional team members.
You're the right fit if: You've acquired a minimum of 7 years' experience in Regulatory Affairs within FDA regulated Medical Device, with expertise in the Preparation, Authoring and Submission of 510K's, PMA, China NMPA, De Novo, Technical Documentation, and EU MDR /International regulatory submissions/registrations required.
You have proven experience with Software as Medical Device (SaMD), and Ultrasound Imaging Devices (preferred).
You have a strong understanding of all relevant global regulatory requirements, flexibility and adaptability to adjust to business needs, and strong communication skills.
You have a minimum of a Bachelors degree (required) in Regulatory Affairs, a technical/Engineering or business discipline.
RAC preferred.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this 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 Reedsville, PA is $105,000 to $178,000.
The pay range for this position in Plymouth, MN or Chicago, IL is $109,000 to $187,000.
The pay range for this position in Bothell, WA, Cambridge, MA or San Diego, CA is $116,000 to $200,000.
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, Reedsville, PA, Chicago, IL, San Diego, CA, Bothell, WA or Cambridge, MA.
#LI-PH1
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/Disabled/Veteran and maintains a drug-free workplace.