ObjectWin Technology
Regulatory Affairs Specialist II
PayCompetitive
LocationNorwalk/Connecticut
Employment typeFull-Time
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Job Description
- Req#: 21-00991
Regulatory Affairs Specialist II
Norwalk, Connecticut - 6851
6 months Contract
Interviews will be via Teams by the manager
WILL BE REMOTE
min 2 years' experience
Key must haves:
***Competency of FDA product labeling compliance - developing ingredient statements & nutrition fact panels & claims substantiation
knowledge of USDA bio-engineering regulations
MS office skills
Optiva experience is a nice have
BS in Food Science, Nutrition or similar is REQUIRED
SEE ATTACHED JOB DESCRIPTION:
BS Food Science, Nutrition or related science preferred
Minimum 2 years of related experience with a food or beverage company
Competency with FDA and USDA labeling requirements
Competency in MS Office. Familiarity with Optiva a plus
Excellent communication, inter-personal and team skills
Strong organization and prioritization skills
Ability to work quickly with accuracy
Too much work for internal resources to manage. Government compliance deadline for this project is 1/1/2022. Project had a delayed start due to SAP implementation resource requirements.
Work is extensive and cannot be absorbed by current team. Workload will be a short term crunch requiring additional resources to manage in the within tight timeline.
Plan is to complete project work by end of July 2021 to allow 6-month flow through of existing package inventory. Contingent contract could be extended if July completion date is not met.
Description:
* Compile and maintain regulatory documentation databases or systems.
* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Analyze product complaints and make recommendations regarding their reportability.
* Develop or conduct employee regulatory training.
* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
* Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects.
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
* Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
* Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
* Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
* Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
* Participate in internal or external audits.
* Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
* Prepare or maintain technical files as necessary to obtain and sustain product approval.
* Recommend changes to company procedures in response to changes in regulations or standards.
* Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
* Review clinical protocols to ensure collection of data needed for regulatory submissions.
* Write or update standard operating procedures, work instructions, or policies.
* Coordinate recall or market withdrawal activities as necessary.
* Develop or track quality metrics.
* Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
* Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
* Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
* Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
* Monitor national or international legislation on ozone-depleting substances or global warming.
* Obtain clearances for the use of recycled plastics in product packaging.
* Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
* Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.About the company
ObjectWin provides global workforce solutions,ObjectWin,Workforce Solutions,IT Solutions,Staffing and Staffing Industry to meet current and future business demands of our customers.