Supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's de ...gree. Typically reports to a supervisor or manager. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2 -4 years of related experience.More Show Less
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This job offer is not available in your country. Title. Regulatory Affairs Specialist. Location. Scarborough, ME. Shift. Mon - Fri am to pm. RESPONSIBILITIES. Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified ...
We believe that great healthcare is an essential safeguard of human dignity. . At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. . . We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re...
1 year contract with possible extension and conversion to permanent employment. Hybrid position- 3 days on site T, TH and tbd. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other relate...
Job Title. Regulatory Affairs Specialist II. Location - 2901 Harbor Bay Parkway, Alameda, CA 94502. Duration – 12 Months. Pay rate - $59/hr. Years of Experience. At least 5 years. Location. On-Site (5-days a week). Experience Background (Any). Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering. Job Description (Expectation). Re...
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care. . Wha...
8/1/23 Nadine - We just spoke with the hiring manager, and he updated the role with the below notes. Need to understand the process to commercialize and go to market with a new assay. Understands the purpose of a design control. Understand the process of going to a clinical trial and the documents needed. Understand the regulations and requirements around submitting a device to an agency in EU, UK, and rest of world. Knows what doing a submission...
Regulatory Affairs Specialist II. . With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing litera...
Responsibilities. . . You are responsible for regulatory submissions and regulatory compliance for currently marketed products, as necessary, to ensure ongoing compliance. . Regulatory representative on core teams providing regulatory input and guidance throughout the product development cycle. . Work on development of pre-submission strategy/regulatory pathway, provide input on testing requirements for new and modified product. . Assess software...
MAIN JOB RESPONSIBILITIES / COMPETENCIES. 1. Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports. 2. Review/Prepare Standard Operating Procedures (SOPs). 3. Compile information necessary for periodic reports for Regulatory f...
