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Principal Regulatory Affairs Specialist
2 days 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 ...
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Regulatory Affairs Specialist
1 week ago
Randstad North America, Inc. Cambridge, United StatesAs 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 ...
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Regulatory affairs specialist
6 days ago
Randstad Cambridge, United Statesjob 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 ...
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Regulatory Affairs Specialist
1 week 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 ...
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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 ...
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Principal Regulatory Affairs Specialist
4 days ago
Philips Iberica SAU Cambridge, United StatesJob 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 ...
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Scientific Affairs Specialist
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Bruker Billerica, MA, United States· Scientific Affairs Specialist · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Research & Development · Overview · As one of the world's leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields ...
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Principal Regulatory Affairs Specialist
5 days ago
Philips Iberica SAU Cambridge, United StatesJob 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 ...
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Principal Regulatory Affairs Specialist
1 week 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 clini ...
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Principal Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJob 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 ...
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Principal Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United StatesJob 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 ...
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Principal Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United StatesJob 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) ...
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Principal Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United StatesJob 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 ...
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Senior Regulatory Affairs Specialist
6 days ago
Validation Associates Cambridge, United StatesContract 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 ...
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Senior Regulatory Affairs Specialist
1 week ago
Validation Associates Cambridge, United StatesContract 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) · Cont ...
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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 ...
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Senior Regulatory Affairs Specialist
1 week ago
VALIDATION ASSOCIATES LLC Cambridge, United StatesJob Description · Job Description · 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. · Ma ...
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Regulatory Affairs Specialist
21 hours ago
CERES Group Westborough, United StatesRegulatory Affairs Specialist · Location: Marlborough, Massachusetts · Do you have a proven track record of working with Regulations and the implementation of labeling for Medical Device UDI project? Do you want to work on a fantastic team as they undergo the changes for the EU M ...
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Ardelyx Waltham, United StatesArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as earl ...
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Ardelyx Waltham, United States· Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as e ...
Senior Regulatory Affairs Specialist - Needham Heights, United States - Biofourmis
Description
The 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.
Supporting and maintaining the pharma partnership product strategies and deliverables within the assigned project teams
Managing compliance to the requirements established by applicable Regulatory Agencies (Competent Authorities) throughout the assigned projects
Ensuring consistency and delivery of product and services within the implemented market requirements
Managing, reviewing, and approving finished product specifications prior to market launch and implementation
Supporting key processes that require timely and effective execution
Providing guidance to product development and manufacturing teams to ensure compliance to applicable requirements and regulations
Job Overview:
Provides guidance and support on key product and project deliverables to ensure the effective achievement of business objectives with full regulatory compliance
Has broad expertise and unique domain knowledge in the areas of clinical research, clinical investigation, pharma development, medical device product development, manufacturing, regulatory submissions, and quality management in the applicable markets
Has the necessary technical, educational, and work experience (in both medical devices and pharmaceuticals) to become highly knowledgeable with the organizations products.
Works on complex challenges that require in depth knowledge of quality and regulatory principles and practices
Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements
Minimum Requirements
Typically requires a scientific degree within Engineering, data science, computer science, or other relevant technical discipline with 8 years similar experience in regulated industry, 5 years with a Masters, and 3 years with a PhD.
Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR parts 50 (GCPs), 803, 806, 812, and 820, ISO 13485, 14971, ICH E6, EU MDR, Canadian MDR, and ANVISA.
10+ years experience in regulated medical devices and / or pharmaceuticals developing, conducting, and executing clinical and regulatory strategy and submissions.
Knowledge of pharmaceutical development, sensor based Digital Health Technologies, and hardware based device development, compliance testing, and documentation desired.
Base salary range for this position is $90,000 to $130,000 based upon experience.
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