Regulatory Affairs Specialist - Cambridge, United States - Philips

Philips Cambridge, United States

3 weeks ago

Full time

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 creating a better and fairer future for all.

In this role you have the opportunity to

Establish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities

Your role:

Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products
Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy
Responsible for regulatory planning for new product introductions and product changes, and ensuring maintenance of global regulatory compliance
Responsible for product registration submissions/approvals as well as license renewals and updates for EU and further worldwide locations
Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed
Continuously analyze US, EU, and international regulatory requirements and initiate relevant design changes
Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements
Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations
Provide Regulatory support for Audit, IIA and CAPA
Other support as needed by the business

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Bachelor's degree or equivalent internationally acquired qualification preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
Medical device regulatory approvals and submittal experience across global markets
Working knowledge of international and industry standards (i.e., ISO/IEC 60601 series, ISO 10993 series, etc.)
Experience with evaluation of design, manufacturing, supplier changes paired with the ability to work cross functionally in a multinational organization
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and a high attention to detail with minimal supervision.
Excellent personal and intercultural skills that include:
Solution and detail-oriented
Well organized and self-motivated
Team spirit and good communication skills
Willingness and open for self-improvement

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.

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 Details

The pay range for this position is $74,000,000 to $136,000, 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.

#LI-PHI

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.

Principal Regulatory Affairs Specialist

2 weeks 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 ...
Public Affairs Specialist

2 days ago

U.S. Department of Justice Boston, United States

Summary · 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 ...
Research Affairs Specialist

6 days ago

Tufts University Boston, United States

Overview: · 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 ...
Regulatory Affairs Specialist

3 weeks ago

Randstad North America, Inc. Cambridge, United States

As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs, Specialis ...
regulatory affairs specialist

1 week ago

Randstad Cambridge, United States

regulatory affairs specialist (cambridge). · cambridge , massachusetts · posted 3 days ago · job details · summary · $65 - $80 per hour · contract · bachelor degree · category computer and mathematical occupations · reference · job details · job summary · Your Respons ...
Regulatory affairs specialist

2 weeks ago

Randstad Cambridge, United States

job summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...
Regulatory Affairs Specialist

3 days ago

Philips Cambridge, United States Full time

JOB 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

1 week ago

Philips Cambridge, United States Full time

JOB 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 ...
Medical Affairs Specialist

1 week ago

Philips Cambridge, United States Full time

Job Title · Medical Affairs SpecialistJob Description · As a Medical Affairs Specialist, you will help to develop the Medical Office within HPM, contribute with clinical context in the whole lifecycle of our solutions and products. In close contact with selected customers and adv ...
Regulatory Affairs Specialist

3 days ago

Philips Cambridge, United States Full time

Job 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 ...
Regulatory Affairs Specialist I

1 week ago

Johnson & Johnson Raynham, United States

DePuy Synthes, part of Johnson & Johnson MedTech, is recruiting for a **Regulatory Affairs Specialist I **to support our Spine business. _This role is located on-site in Raynham, MA and will work a Flex/Hybrid schedule with three days of on-site and two days of off-site work _. · ...
Principal Regulatory Affairs Specialist

2 weeks ago

Philips Iberica SAU Cambridge, United States

Job Title Principal Regulatory Affairs Specialist Job Description 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 ...
Principal Regulatory Affairs Specialist

6 days ago

Philips Cambridge, United States

Job 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 ...
Principal Regulatory Affairs Specialist

2 weeks ago

Philips Iberica SAU Cambridge, United States

Job Title Principal Regulatory Affairs Specialist Job Description · 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 possib ...
Principal Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States

Job TitlePrincipal 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 ...
Principal Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States

Job 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 clini ...
Principal Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States Full time

Job Title · Principal Regulatory Affairs SpecialistJob 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 ...
Principal Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States

Job TitlePrincipal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · If your skills, experience, and qualifications match those in this job overview, do not delay your application. · Clinical Integration and Insight (CII) ...
Principal Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States

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 i ...
Senior Regulatory Affairs Specialist

2 weeks ago

Validation Associates Cambridge, United States

Contract Role:Schedule: It will be on average 20 hours per week, preferably 4 hours a day M-F, but we can be flexible depending on the candidate.-REMOTE- Regulatory Affairs Specialist DS Process Expert with NDA filing experience.May September (20 hours week)Contractor to support ...