- 192018 - Regulatory Affairs Specialist
- NJ-New Jersey
- Fair Lawn
- Up to $42.00 DOE
- 12 mos
- Chipton-Ross is seeking a Regulatory Affairs Specialist for an opening in Fair Lawn, NJ.
Serve as a team contact to gather product regulatory information into appropriate systems, spreadsheets and documents. Responsible for ensuring that product regulatory data input and approvals for SKU requests are processed within agreed-upon service level agreements. Accountable for ensuring that all SKU launches and extensions are expedited on schedule. Review product labeling for compliance with applicable regulations and standards. Participate in Project Teams as required. Provide regulatory support for the core SKU Management processes including SKU creation and discontinuation. Responsible for driving key initiatives to clean existing SKU data and create tools, processes and mechanisms for maintaining clean SKU data over time. Keep abreast of new or revised regulations regarding IVD Medical Devices and provide guidance to team as needed. Conduct training and/or communicate appropriate material to internal staff to aid in compliance. May be required to perform other related duties as required and/or assigned.
Serve as a member of the Global Regulatory Affairs department. Function as a direct link between the Global and Local QA team members to ensure local and regional regulatory strategies are developed and aligned. Act as subject matter expert regarding customer complaint processing, adverse event reporting, and, field action, and recall reporting. Independently lead others and conduct regulatory assessments with minimal guidance or supervision. Responsible for SOP revisions/document creation/annual document review as assigned. Review customer notifications. Interface with Quality Assurance and Customer Facing Teams for product investigations and trend reporting.
Minimum 2 years’ experience in importing and exporting in the Life Sciences industry OR 2 years Life Sciences industry experience including Chemical Knowledge related to TSCA, REACH, etc. Computer database and spreadsheet proficiency. Demonstrated ability to focus on project work and efficiently bring projects to completion. Strong ability to influence others and interpret government regulations. High energy level; positive attitude; works well under stress, Strong communicator, Team player. Hands-on, action-oriented, and able to implement effectively through his/her team. Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency. Able to work autonomously in a matrix-managed organization. Willingness to travel (10-15%). Comfortable with ambiguity and change
Accredited B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
11832 Fishing Point Drive, Suite 100
Newport News, VA 23606
Phone: (757) 595-0005 x261 or (877) 244-5418 x261
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.