Philips Iberica SAU
Principal Ultrasound Regulatory Affairs Specialist
Philips Iberica SAU, Cambridge, Massachusetts, us, 02140
Job Title Principal Ultrasound Regulatory Affairs Specialist Job Description
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business.Your role:Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.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 communication and negotiation efforts with regulatory enforcement 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, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.Ensure compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect.Provide regulatory support for (pre) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.Represents Philips in internal and external audits with regulatory agencies or Notified Bodies as needed.Mentor and coach Philips regulatory professionals in their development; drive improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained.Reporting to the Director of Regulatory Affairs-Ultrasound, you will collaborate with regulatory Affairs team members globally, Engineering, R&D, Manufacturing and other cross-functional team members.This
Hybrid
role may require travel up to 10%.Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to Cambridge, MA.You're the right fit if:You’ve acquired a minimum of 7 years' experience in FDA regulated Medical Device Regulatory Affairs, with proven expertise in U.S. FDA 510K, China NMPA, and EU MDR and International regulatory submission authoring experience required.You have a proven track record in the successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.You have 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 or business discipline, Advanced Degree (MS/PhD)- desired. 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.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.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.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.
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The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business.Your role:Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.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 communication and negotiation efforts with regulatory enforcement 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, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.Ensure compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect.Provide regulatory support for (pre) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.Represents Philips in internal and external audits with regulatory agencies or Notified Bodies as needed.Mentor and coach Philips regulatory professionals in their development; drive improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained.Reporting to the Director of Regulatory Affairs-Ultrasound, you will collaborate with regulatory Affairs team members globally, Engineering, R&D, Manufacturing and other cross-functional team members.This
Hybrid
role may require travel up to 10%.Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to Cambridge, MA.You're the right fit if:You’ve acquired a minimum of 7 years' experience in FDA regulated Medical Device Regulatory Affairs, with proven expertise in U.S. FDA 510K, China NMPA, and EU MDR and International regulatory submission authoring experience required.You have a proven track record in the successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.You have 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 or business discipline, Advanced Degree (MS/PhD)- desired. 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.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.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.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.
#J-18808-Ljbffr