Principal Regulatory Affairs Specialist - Cambridge, United States - Philips

Description

Job TitlePrincipal Regulatory Affairs SpecialistJob 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:

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 FDA's 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.


You're the right fit if:

You've 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 bachelor's of science degree or higher in a technical discipline; Master's 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.

You're an excellent communicator, with strong project management and stakeholder management skills,About PhilipsWe 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 DetailsThe 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 InformationUS 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-PH1This 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