- 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. The specialist acts as a liaison between the Market Access Team and the FDA. 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.
- Bachelor's Degree in a scientific or engineering discipline plus 5 or more years relevant experience in the area of In Vitro Diagnostics. Applicants with educational backgrounds in Regulatory Affairs or related Health Care Management Degrees are preferred.
- Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project) is required.
- 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.
-
Auto Physical Damage Supervisor
2 days ago
Plymouth Rock Assurance Parsippany, United StatesOverview: · **Auto Physical Damage Supervisor** · We are currently seeking an Auto Physical Damage (PD) Supervisor to join our growing Personal Lines Auto team in our Farmington, CT or Parsippany, NJ offices. · The PD Supervisor is responsible for managing, coaching and developin ...
-
Attendance Specialist/attendance Caseworker
2 days ago
Grundy / Kendall Regional Office of Education #24 Morris, United StatesAttendance specialist will provide prevention/intervention services for schools in Grundy County. The Attendance Specialist will: accept referrals from assigned school district based upon specified criteria, conduct an educational history, conduct student and/or parent conference ...
-
Project Specialist Staff
2 days ago
Strategic Education Inc. Newark, NJ, United StatesThe Assessment Specialist measures learning outcomes at the institutional, program, and course level, develops and validates new instruments, provides evidence to support the credibility of learning outcomes data, and facilitates the use of learning outcome data. The Assessment S ...
-
Staff Administrative Specialist
1 week ago
U.S. Army Reserve Command New York, United StatesSummary · About the Position: This is a military technician position with the 377th Theater Sustainment Command, 354 Transportation Battalion, 77 Sustainment Brigade, 316 Sustainment Command (Expeditionary) located at Fort Totten, New York. · This position requires an active me ...
-
Specialist - Medical Staff
20 hours ago
GOODWIN New York, NY, United StatesWe are in the business of building authentic, long-term relationships with our clients, who are some of the world's most successful and innovative investors, entrepreneurs and disruptors in the life sciences, private equity, real estate, technology and financial industries, and w ...
-
Junior IT Support Specialist
1 week ago
Horizon Ventures Morris, United StatesDo your thing at NT-ware. · We are an innovation partner and an integral part of the Canon Group. Our specialists worldwide develop state-of-the-art software for print and scan management in close proximity to Osnabrück: "from scratch" and in constant exchange with colleagues in ...
-
Private Customer Advisor
2 weeks ago
Terra Nova Group Morristown, NJ, United States Freelance**Please note**: · If the location of work does not suit you, discover your professional future without location boundaries - we are looking for candidates in the entire state · Are you coming from a cooperative bank, credit union, or private bank? · Then you are in the right pla ...
-
staff clinical evaluation specialist
1 week ago
Stryker Corporation Mahwah, NJ , USA, United StatesIn your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team, you will lead the process of planning, writing, and updating Clinical Evaluation documentation (e.g., CE - Rs, CE - Ps, SSCPs, PMCF - Ps, PMCF - Rs) to bring State o Evaluation, Clinical, Clinica ...
-
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 clinical evaluation specialist
5 days ago
Stryker Corporation Mahwah, NJ , USA, 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 (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 Regulatory Affairs Specialist
1 week 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 evaluation specialist
1 week ago
Stryker Mahwah, NJ , USA, 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 ...
-
Medical Assistant
2 weeks ago
Matrix Dynamics South Hill, NY, United States FreelanceThe Medical Laboratory Hannover GmbH, located in South Hill, NY, is a multidisciplinary medical care center that provides microbiological, molecular biological, molecular genetic, immunological, immunohematological, endocrinological, clinical-chemical, hematological, and coagulat ...
-
Senior Staff Specialist, Regulatory Compliance
2 weeks ago
Stryker Mahwah, 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, Specialist, Staff, Regulatory, Compliance, 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 ...
-
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 ...
-
Digital Sales Specialist
1 week ago
Wayne Subaru Pompton Plains, United States**Purpose of this Role**: · The Digital Sales Specialist will be the first point of contact for a consumer contacting Wayne Subaru when shopping online for a new or pre-owned Subaru. Contact is via the internet from multiple points of contact with us. The Digital Sales Specialist ...
-
Warehouse worker
1 week ago
Sapphire Enterprises Short Hills, United StatesWe are Trio Personalmanagement - your regional personnel service provider. · Our entire management team, employees, and staff bring years of experience in temporary staffing, recruitment, sales, customer service, recruiting, and employee care, and are dedicated to their work with ...
-
Medical Biller/ Denial Specialist
1 week ago
NJ Eye and Ear, LLC Clifton, United States**IF YOU HAVE NOT WORKED IN A BILLING POSITION, PLEASE DO NOT APPLY** · NJ Eye and Ear is a modern, multi-specialty healthcare provider with offices in Clifton and Englewood, NJ. We strive to provide an unparalleled eye care experience to each of our patients. Our passionate team ...
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:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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)
