- Plan, generate, and lead global regulatory strategy for wearable devices, Software as a Medical Device (SaMD), including AI enabled algorithms within Innovation & Strategy and CTO and ensure consistent approach across all clusters.
- Provide regulatory subject matter expertise, guidance and support to all critical advanced development activities within the Philips Research organization.
- Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects and the regulatory management team.
- Lead regulatory submission activities, and directly interact and negotiate with pertinent regulatory authorities on regulatory filings to achieve on time approvals.
- 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.
- Provide guidance on global compliance, such as CE Marking and product registrations, China NMPA, Canadian CMDCAS, Japan PMDA, compliance with FDAs guidance documents, and including requirements that are relevant to the overall Philips Innovation & Strategy priorities globally.
- Ensuring compliance with the current regulatory procedures and where needed, generating new and/or update procedures when new regulatory requirements are determined to go into effect.
- Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
- Where applicable, represent Philips in an international committee chartered to develop AI regulatory framework.
- Youve acquired 7+ years of experience in the FDA regulated Medical Device industry executing regulatory strategies, compiling technical documentations and regulatory submission packages for software enabled medical devices.
- Your skills include experience or working knowledge of applicable standards including software development lifecycle, risk management and cybersecurity in medical devices required. Experience in executing regulatory strategies for AI enabled Medical Devices preferred. Experience with US FDA pre-submissions, 510(k) submissions required. Experience with US FDA De Novo, CE marking under MDD/MDR and international registration in emerging markets such as India-preferred. Ultrasound and Obstetrics device experience is a plus.
- You have a bachelors of science degree or higher in a technical discipline; Masters preferred.
- 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.
- Youre an excellent communicator, with strong project management and stakeholder management skills,
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
-
Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
-
Principal Regulatory Affairs Specialist
1 week ago
National Black MBA Association Cambridge, United StatesJob TitlePrincipal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) · The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to ...
-
Principal Regulatory Affairs Specialist
2 weeks ago
BRIOHEALTH SOLUTIONS INC Boston, United StatesJob Description · Job DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you'll support product development ...
-
Philips North America Cambridge, United StatesJob TitlePrincipal Regulatory Affairs Specialist, Software · Job Description · Principal Regulatory Affairs Specialist, Software (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance p ...
-
Public Affairs Specialist
3 weeks ago
U.S. Department of Justice Boston, United StatesSummary · This job is open to · Career transition (CTAP, ICTAP, RPL) · Federal employees who meet the definition of a "surplus" or "displaced" employee. · Family of overseas employees · Family members of a federal employee or uniformed service member who is or was, working overse ...
-
Principal Regulatory Affairs Specialist
4 weeks ago
Philips Cambridge, United StatesJob Title Principal Regulatory Affairs Specialist Job Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical ...
-
Research Affairs Specialist
4 weeks ago
Tufts University Boston, United StatesOverview: · Dental Research Administration (DRA) at TUSDM is the main research structure for all basic science and clinical projects at the Dental School. DRA is the liaison to the Office of the Vice Provost, Sponsored Accounting, IRB, IACUC, DLAM, Biosafety and all other offices ...
-
Principal Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
-
Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJob Title · Principal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) · The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies t ...
-
Partners HealthCare Boston, United States Full timeDescription Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as ...
-
Medical Affairs Specialist
5 days ago
Masis Professional Group Wilmington, United StatesMedical Affairs Specialist, US (Oncology, Endocrinology, Radiopharmaceuticals) · Location: Hybrid - NYC or MA · Company Overview: · Join a small but groundbreaking radiopharmaceutical development organization that retains its start-up spirit and is deeply committed to advancing p ...
-
Associate Medical Affairs Specialist
1 week ago
Medtronic Boston, United States**Careers that Change Lives** · This a remote based role reporting to the director of Medical Education for Surgical Robotics for the US region within Medtronic. This role is an important role within the team supporting the education of health care professionals in the safe and e ...
-
Regulatory Affairs Specialist
1 week ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices. · Reviews and summ ...
-
Senior Regulatory Affairs Specialist
1 week ago
Biofourmis Needham Heights, United StatesThe Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes for the Biofourmis pharma partnerships and DTx algorithms. · Reporting to the SVP of Q&R, the Senior Regulatory Affairs S ...
-
Regulatory Affairs Specialist
2 weeks ago
Sunrise Systems Inc Andover, United StatesJob Title: Regulatory Affairs Specialist - Labeling - Junior · Job ID: · Location: Andover, MA · Duration: 12 Months contract on W2 · Description: · Role Overview · Include specific internal and external relationships, product focus, regulatory requirements, physica ...
-
Regulatory Affairs Specialist II/Sr
1 week ago
Nova Biomedical Waltham, United StatesCareer Opportunities with Nova Biomedical Corporation · Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities. · Nova Biomedical is hiring a · Regulatory Affair ...
-
Regulatory Affairs Specialist
1 week ago
Kelly Services, Inc. Bridgewater, United StatesProvide Regulatory Documentation Support to Global RA team members for Product Registrations, Renewals, etc. Provide support and needed information to all global regions on products across the company and subsidiaries product portfolio utilizing exte Regulatory Affairs, Specialis ...
-
Regulatory Affairs Specialist
2 weeks ago
Actalent Bedford, United States**Language fluency required: English & Chinese essential** · Position Summary: · The Regulatory Specialist will be responsible for China NMPA and Japan PMDA registration and renewal activities. Related duties include participation on design and risk management teams, initiation ...
-
External Affairs Specialist
3 weeks ago
Breathe Pennsylvania Cranberry, United StatesOrganization Overview: Breathe PA helps residents of western Pennsylvania achieve and maintain optimal lung health through education, prevention, and direct services.Responsibilities and Qualifications: The External Affairs Specialist provides support to organization-wide communi ...
Principal Regulatory Affairs Specialist - Cambridge, United States - Philips North America
Description
Job TitlePrincipal Regulatory Affairs Specialist
Job DescriptionPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based)
The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organization globally. You will work closely with various stakeholders from global Philips Innovation Hubs, and regulatory leaders from different clusters, to enable and accelerate regulatory approvals for innovative solutions in all target markets.
Your role:
You're the right fit if:
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.
If youre 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 $104,300 to $200,256, 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.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted location(s).
#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.
