What are the responsibilities and job description for the Principal Consultant position at Nelson Laboratories Holdings, LLC?
The Principal Consultant is an expert and lead in technical consults. They will oversee, write, and research client projects to safeguard global health. This will also include the review of all necessary written information (e.g., Product Adoptions, Test Plans, FDA Responses) from peers and any additional research or other considerations. Education & Experience Required :
- Bachelor's degree or higher in a relevant Life Science (Biology, Chemistry, Genetics, Bioengineering, Biotechnology, Toxicology, or similar).
- 10 years of experience in Biocompatibility (or 5 years with a Masters degree or higher).
- Extensive experience with ISO 10993.
- Strong technical writing skills.
- Experience presenting to clients and stakeholders in virtual and in-person settings.
- Ability to mentor team members. Preferred (Not Required) :
- Master's degree or higher in a relevant Life Science. Essential Duties - Principal Consultant Consulting
- Review and draft assessments and related documents (e.g., Product Adoptions, Test Plans, FDA Responses).
- Collaborate cross-functionally to ensure expert input.
- Communicate with clients to gather project information.
- Conduct literature research and drive process improvements.
- Uphold the Nelson Service Standard and Code of Ethics.
- Mentor peers and lead scientific direction.
- Engage with global expertise networks.
- Serve as a recognized expert and present at industry events. Regulatory Compliance
- ISO 10993
- Ensure compliance with GMP, GLP, ISO, AAMI, ASTM, and other regulations.
- Participate in regulatory committees and serve as a US ISO Delegate if applicable. Work Environment : This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors, and file cabinets. Typically works in an office environment but may occasionally be required to perform job duties outside of the typical office setting. #remote Travel requirements : Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend domestic and international trade shows, seminars, client visits and conferences. Physical requirements : Must be able to stand / walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to attend trade shows, seminars, standards meetings, client visits, and conferences. Must be able to occasionally lift a maximum of 45lbs. May require modified work hours to cover travel and work in other time zones.
