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Posted: Saturday, January 20, 2018 3:48 AM

Job Description:/h3:
One of our premier clients here at Russell Tobin is in search of a Senior Project Manager, Regulatory Affairs. This is a direct hire opportunity located in New Jersey. Please see job responsibilities and requirements below. Contact Justin Bell at or Apply at to discuss.
Responsibilities:
:Develop Global Regulatory Strategies
:Leads RA Associates in a dotted line reporting structure
:Leads cross functional project teams to implement RA and compliance initiatives
:Research device classification and evaluate predicate devices
:Create 510(k) Submissions for a range of medical devices.
:Provide Regulatory support for a broad range of international registration activities
:Provide periodic regulatory training and education, both internally and externally
:Coordinating responses to client questionnaires, requests and queries
:Working with product design, development and testing teams to ensure medical device regulatory access
:Maintain familiarity with global medical device regulations and national certification schemes
:Assist product teams with regulatory risk assessment and management.
:Provide support as an interface with regulatory authorities on regulatory and technical matters, as appropriate.
:Interface with appropriate governmental agencies on project/products. Assist in the preparation of special and periodic reports for FDA.
:Develop appropriate regulatory reports and associated documentation in accordance with SOPs and specific regulatory processes.
:Prepare and manage FDA documents required to initiate regulated studies (522 Order)
:Assist R and D, Marketing, and North America Operations QA/QC groups in determining that regulatory requirements are met.
:Provide support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval.
Qualifications:
:BA and/or BS degree in Science, Engineering or equivalent, Masters degree preferred
:RAC preferred
:Minimum of 5 years regulatory affairs experience
:In depth experience with FDA requirements, guidance documents, 510(k)
:submissions, Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other
:global regulatory requirements and quality standards involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA), and working with cross:functional project teams.
:History of successful device submissions
:Knowledge of GLP/GCP requirements
:Familiarity with regulatory requirements and standards governing global manufacturing and distribution of FDA regulated products;
:Detail oriented, high degree of accuracy, deadline driven;
:Strong organizational skills with the ability to actively contribute to new projects;
:Excellent communication, interpersonal and time management skills;
:Displays Leadership skills in a matrix environment
:Flexibility in the ability to prioritize, multi task, and learn quickly with a positive attitude.
:Strong negotiation skills and written/oral communication skills
:Strong organizational skills and time management skills
:Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
:Ability to work independently and under general direction only
:Computer skills; MS Office, MS Project, Adobe Acrobat, Agile

Company Description:/h3:
Russell Tobin, one of the nations leading professional recruitment and staffing advisory firms, offers a tailored approach to helping organizations connect with direct hire and contract employees across a variety of skillsets and industries. Having a depth and breadth of industry expertise, our talent advisors and recruitment specialists are able to provide customized and swift solutions to fulfill client and candidate hiring needs.We work with each and every candidate to assess their respective goals and subse

Source: https://www.tiptopjob.com/jobs/77135107_job.asp?source=backpage


• Location: Hudson Valley

• Post ID: 35310272 hudsonvalley
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