-
Regulatory Affairs Staff Specialist
3 weeks ago
Stago Parsippany-Troy Hills, United States Full timeSummary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicab ...
-
Regulatory Affairs Staff Specialist
1 week ago
Diagnostica Stago Parsippany, United StatesSummary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicab ...
-
Regulatory Affairs Staff Specialist
1 week ago
Stago Parsippany, United StatesSummary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicab ...
-
Specialist - Medical Staff
1 week ago
CASES Brooklyn, NY, United States Full timeThe purpose of Assertive Community Treatment (ACT) is to deliver comprehensive and effective services to individuals (age 18 and up) who are diagnosed with serious mental illness (SMI) and whose needs have not been well met by more traditional service delivery approaches. These i ...
-
Stryker Mahwah, United States Full timeWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new thi ...
-
staff specialist, graduate school
1 week ago
Uncommon Schools New York, NY, United States Full timeUncommon Schools (Uncommon) is a nonprofit organization that starts and manages outstanding urban charter public schools that close the achievement gap and prepare low-income students to graduate from college. Uncommon builds uncommonly great schools by developing and managing re ...
-
Staff Accountant/AR Specialist
1 week ago
CCS Fundraising New York, United States· Title: Staff Accountant/AR Specialist · Location: New York, NY · Department: Finance · Type: Full Time · This position is not eligible for employer visa sponsorship. · Who We Are · CCS Fundraising is an international strategic fundraising firm that partners with nonprofi ...
-
Staff Regulatory Affairs Specialist
2 weeks ago
BD (Becton, Dickinson and Company) Franklin Lakes, United States**Job Description Summary** · The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the project level in developing and executing regulatory strategy and compliance plans to promote and support drug delive ...
-
Staff Clinical Compliance Specialist
2 weeks ago
Danaher Corporation New York, United StatesAt first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrou ...
-
Staff Regulatory Compliance Specialist
3 weeks ago
Stryker Corporation Mahwah, United StatesWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new thi ...
-
Staff Regulatory Affairs Specialist
2 weeks ago
BD Franklin Lakes, United StatesJob Description Summary · The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the project level in developing and executing regulatory strategy and compliance plans to promote and support drug delivery s ...
-
Staff Clinical Evaluation Specialist
2 weeks ago
Stryker Mahwah, United StatesWhy join Stryker? · We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting · Stryker is one of the world's leading medical technology companies and, together w ...
-
Staff Regulatory Affairs Specialist
1 week ago
BD Franklin Lakes, United StatesJob Description Summary · The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the project level in developing and executing regulatory strategy and compliance plans to promote and support drug delivery s ...
-
Staff Regulatory Compliance Specialist
1 week ago
Stryker Mahwah, United StatesWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new th ...
-
Senior Staff Regulatory Affairs Specialist,
4 weeks ago
Stryker Allendale, United StatesHere, we provide our RA/ QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World's Best Workplaces, Regulatory Affairs, Specialist, Staff, Regulatory, Senior, Manufacturing, Technology · ...
-
CAMBA New York, United StatesJob Description · Job DescriptionWho We Are: CAMBA is a community of staff, volunteers, clients, donors, neighbors and partners who work together to build an inclusive New York City. CAMBA serves more than 65,000 individuals and families each year, citywide, including almost 13,0 ...
-
Stryker Mahwah, United StatesWhy RA/QA at Stryker? · Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new th ...
-
CAMBA Brooklyn, United StatesWho We Are:CAMBA is a community of staff, volunteers, clients, donors, neighbors and partners who work together to build an inclusive New York City. CAMBA serves more than 65,000 individuals and families each year, citywide, including almost 13,000 youth. Our 180+ programs in ove ...
-
Support Staff Specialist
3 weeks ago
BHC Partners Newark, United StatesSupport Staff Specialist/Certified Medical Assistant (CMA)Position available for our mobile unit in Licking CountyDuties: In this role, you will be performing front desk and administrative functions to support office operations and clinical staff. You will greet and serve clients ...
-
Support Staff Specialist
3 weeks ago
BHC Partners Newark, United StatesSupport Staff Specialist/Certified Medical Assistant (CMA) · Position available for our mobile unit in Licking County · Duties: In this role, you will be performing front desk and administrative functions to support office operations and clinical staff. You will greet and serve c ...
Regulatory Affairs Staff Specialist - Parsippany, United States - Stago
Description
Summary:
Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicable FDA regulations and guidelines.
This includes preparing and submitting regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications and Premarket Approval (PMA) applications, and ensuring they contain accurate and complete information.
Contributes to the development of regulatory strategies for bringing devices to market or making changes to existing devices.This involves staying updated on FDA regulations, guidelines, and industry standards, and providing guidance to the development and manufacturing teams.
Essential Duties and Responsibilities:
Responsible for the review, maintenance and monitoring of documentation related to the device's regulatory compliance, such as technical files, design dossiers, and labeling requirements.
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access.
Identifies regulatory pathways for initial product designs and provides input to internal stakeholders in preparation of FDA 510 K and De Novo submissions using a risk-based approach.
Analyzes and communicate the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes.
Write and review regulatory documents with a critical eye for suitability for submissions to FDA and any other regulatory agencies as need be.
Under the direction of the Director of US Market Access, handles the preparation of electronic submission packages for regulatory agencies in compliance with applicable requirements & best practices.
Evaluate regulatory policy and critically assesses the impact of changing regulations on pre-approval and post-approval strategies and approaches and advises internal stakeholders on a course of action.
Participate in multidisciplinary project teams within the US Market Access Department providing guidance and direction on current regulatory pathways and expectations.
Stay current on changes to the regulatory environment that could impact new product submission strategies.Work closely with quality assurance and quality control teams to establish and maintain appropriate quality systems for IVDs. This includes ensuring compliance with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).
Establishes working relationships and interfaces and with multiple government and non-government organizations having an impact on market access and distribution.
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).Frames issues with a thorough understanding of legislation, regulations, guidance, policy and directives.
Creates work plans with appropriate staging of activities and with clearly defined milestones.
Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
Provides strategic input and technical guidance on global regulatory requirements to product development teams.Work with document control group to ensure regulatory document archiving.
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
Participates and/or leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
Establishes and maintains business relationships with officials in federal and state government regulatory agencies.
Performs other related duties as assigned.
Education and/or Experience:
Bachelor's Degree in a scientific or engineering discipline plus 5 or more years relevant experience in Regulatory Affairs in the area of In Vitro Diagnostics.
Active participation in regulatory industry associations is a plus; RAC preferred.
Strong critical thinking and analytical skills are required.
Good understanding of the IVD marketplace and have ability to analyze the impact of new regulations, interpret policies in clear terms, and identify the best ways to comply with regulations using a risk-based approach experience in the hands-on preparation of 510(k) submissions for In Vitro Diagnostic products required.
Prior facilitation of meetings with regulators will be considered as a valuable asset. Experience in working with regulatory consultants and contract research organizations is a plus. Excellent analytical and writing skills. Excellent interpersonal, written and oral communication skills. Prior Diagnostics experience is required.Fluency in French is a plus.
Up to 30% Travel (International and Domestic) may be required depending on project demands.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)#J-18808-Ljbffr