Principal Regulatory Affairs Specialist

Principal Regulatory Affairs SpecialistAs a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements.Your Role:Leads business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that requirements are maintained. Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management. Mentor and coach Philips Ultrasound regulatory professionals in their development.Will negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA's guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.As needed, you will represent Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body. May represent Philips in an international committee chartered to develop an applicable standard.You're the Right Fit If:You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments. Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired.You have strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS etc. with proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.You're able to work in a large, matrixed organization and collaborate with globally dispersed partners/team members.You have a minimum of a Bachelor's Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines (Required). Master's degree, RAC Certification desired.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 a part. 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 Bothell, WA/Cambridge, MA is $128,520 to $205,632.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 Bothell, WA or Cambridge, MA.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.