Regulatory Affairs Specialist II

ObjectWin Technology; Norwalk (CT); Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist II to join their team in a fully remote capacity. This role is crucial for ensuring compliance with FDA product labeling and USDA bio-engineering regulations. You will be responsible for maintaining regulatory documentation, coordinating submissions, and advising project teams on regulatory requirements. If you have a passion for regulatory affairs and a strong background in food science or nutrition, this opportunity offers a chance to make a significant impact in a dynamic environment. Join a forward-thinking company where your expertise will help shape the future of product compliance and innovation.

Qualifications

• 2+ years of experience in regulatory affairs, particularly in FDA and USDA compliance.
• Strong knowledge of product labeling and documentation requirements.

Responsibilities

• Compile and maintain regulatory documentation and databases.
• Coordinate regulatory submissions and communicate with agencies.
• Review promotional materials for compliance with regulations.

Skills

FDA product labeling compliance

USDA bio-engineering regulations

MS Office skills

Optiva experience

Education

BS in Food Science

BS in Nutrition

Similar field

Tools

Regulatory documentation databases

Job description

Regulatory Affairs Specialist II

Location: Norwalk, Connecticut - 6851

Contract Duration: 6 months

Interviews: Will be via Teams by the manager

Work Arrangement: Remote

Minimum Experience Required: 2 years

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 to have
• BS in Food Science, Nutrition or similar is REQUIRED

Job Description:

1. Compile and maintain regulatory documentation databases or systems.
2. Coordinate efforts associated with the preparation of regulatory documents or submissions.
3. Analyze product complaints and make recommendations regarding their reportability.
4. Develop or conduct employee regulatory training.
5. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
6. Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
7. Coordinate, prepare, or review regulatory submissions for domestic or international projects.
8. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
9. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
10. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
11. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
12. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
13. Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
14. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
15. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
16. Participate in internal or external audits.
17. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
18. Prepare or maintain technical files as necessary to obtain and sustain product approval.
19. Recommend changes to company procedures in response to changes in regulations or standards.
20. Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
21. Review clinical protocols to ensure collection of data needed for regulatory submissions.
22. Write or update standard operating procedures, work instructions, or policies.
23. Coordinate recall or market withdrawal activities as necessary.
24. Develop or track quality metrics.
25. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
26. Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
27. Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
28. Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
29. Monitor national or international legislation on ozone-depleting substances or global warming.
30. Obtain clearances for the use of recycled plastics in product packaging.
31. Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
32. Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.