Job Title: Regulatory Affairs Specialist
Posted by: LifeNet Health on Oct 18, 2021
Location:
Virginia Beach , VAJob Description:
Description
Regulatory Affairs Specialist
Location: Virginia Beach, Virginia
Department: Regulatory Affairs
Job Type: Full-Time
Shift: Monday-Friday, 8:15am-5pm
LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.
How you will contribute to LifeNet Health's success:
As the Regulatory Affairs Specialist you will assist the Regulatory Affairs Team with coordinating and maintaining regulatory information, researching regulatory requirements, performing routine international product registrations, being the Regulatory Affairs representative on Product Development Design Control Teams and reviewing simple promotional materials to be approved. The associate will communicate interdepartmentally and with external distributors. Additionally, the associate will be required to learn LifeNet Health's governing regulations and the Regulatory Affairs function and role, both internally and externally.
What you'll do:
Submissions: Creates and organizes documentation for routine international regulatory submissions for existing products and line extensions. Total Product Life Cycle: Provide regulatory classification for new products, provide regulatory design inputs, review labeling for compliance to LNH standards and country specific requirements, review product testing strategy to meet regulatory requirements as a member of the design control team. Evaluates design and process changes in CCO's for potential notification to international regulatory agencies according to known change types that trigger notification. Regulatory Operations: Creates and maintain regulatory databases, routine reports, and communications. Conducts regulatory intelligence searches. Maintains regulatory files and tracking databases to ensure accurate access to company regulatory information and registration status of company products. Process Improvements and LEAN: Initiates and executes improvement projects using LEAN methodology with moderate supervision. Develops SOPs and forms with input from other stakeholders. Promotional Materials: Conducts reviews of simple advertising and promotional materials for compliance of US laws and regulations
What you'll bring (Minimum Requirements):
Bachelor's Degree of Science in Engineering, Chemistry, Biology, Pre-Med/Health or other science related required. Three (3) years RA team member in medical device, pharmaceutical or biotechnology company contributing to the writing of submissions for product approvals in the US; Experience contributing to Design Control Teams in Product Development required. Five (5) years preferred. Regulatory Affairs Certification preferred.
These would be nice too (Knowledge Skills and Abilities):
Technical Writing: Write and edit technical documents i.e. SOPs, product submissions, and abstracts.Analytical & Strategic Thinking: Ability to think analytically and strategically regarding impact of regulatory changes on products and impact of product changes on international registrations. Time Management: Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls. Research: Research, analyze, integrate and organize information from diverse sourcesCommunication Skills: Ability to communicate and present across diverse audiences, culture and personnel. Preference for a second language i.e. Spanish, German, Portuguese, Italian, French, Chinese, Japanese.Attention to Detail & Accuracy: Demonstrated exceptional attention to detail, ability to multitask, meet deadlines and work independently. Build Relationships: Ability to work with cross-functional teams.
Why work at LifeNet Health?
We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won't find another company with a culture as strong as ours.
403(b) and Pension PlanMedical, dental, and vision coverageCorporate sponsored events (Chili Cook-Off, 5K, Celebration of Life Gala, and many more!)Work-life balance with generous paid time offTuition reimbursementPersonal career and skill development opportunitiesWellness ProgramEmployee Assistance Program (EAP)Dedicated and passionate co-workers
We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Regulatory Affairs Specialist
Location: Virginia Beach, Virginia
Department: Regulatory Affairs
Job Type: Full-Time
Shift: Monday-Friday, 8:15am-5pm
LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.
How you will contribute to LifeNet Health's success:
As the Regulatory Affairs Specialist you will assist the Regulatory Affairs Team with coordinating and maintaining regulatory information, researching regulatory requirements, performing routine international product registrations, being the Regulatory Affairs representative on Product Development Design Control Teams and reviewing simple promotional materials to be approved. The associate will communicate interdepartmentally and with external distributors. Additionally, the associate will be required to learn LifeNet Health's governing regulations and the Regulatory Affairs function and role, both internally and externally.
What you'll do:
Submissions: Creates and organizes documentation for routine international regulatory submissions for existing products and line extensions. Total Product Life Cycle: Provide regulatory classification for new products, provide regulatory design inputs, review labeling for compliance to LNH standards and country specific requirements, review product testing strategy to meet regulatory requirements as a member of the design control team. Evaluates design and process changes in CCO's for potential notification to international regulatory agencies according to known change types that trigger notification. Regulatory Operations: Creates and maintain regulatory databases, routine reports, and communications. Conducts regulatory intelligence searches. Maintains regulatory files and tracking databases to ensure accurate access to company regulatory information and registration status of company products. Process Improvements and LEAN: Initiates and executes improvement projects using LEAN methodology with moderate supervision. Develops SOPs and forms with input from other stakeholders. Promotional Materials: Conducts reviews of simple advertising and promotional materials for compliance of US laws and regulations
What you'll bring (Minimum Requirements):
Bachelor's Degree of Science in Engineering, Chemistry, Biology, Pre-Med/Health or other science related required. Three (3) years RA team member in medical device, pharmaceutical or biotechnology company contributing to the writing of submissions for product approvals in the US; Experience contributing to Design Control Teams in Product Development required. Five (5) years preferred. Regulatory Affairs Certification preferred.
These would be nice too (Knowledge Skills and Abilities):
Technical Writing: Write and edit technical documents i.e. SOPs, product submissions, and abstracts.Analytical & Strategic Thinking: Ability to think analytically and strategically regarding impact of regulatory changes on products and impact of product changes on international registrations. Time Management: Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls. Research: Research, analyze, integrate and organize information from diverse sourcesCommunication Skills: Ability to communicate and present across diverse audiences, culture and personnel. Preference for a second language i.e. Spanish, German, Portuguese, Italian, French, Chinese, Japanese.Attention to Detail & Accuracy: Demonstrated exceptional attention to detail, ability to multitask, meet deadlines and work independently. Build Relationships: Ability to work with cross-functional teams.
Why work at LifeNet Health?
We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won't find another company with a culture as strong as ours.
403(b) and Pension PlanMedical, dental, and vision coverageCorporate sponsored events (Chili Cook-Off, 5K, Celebration of Life Gala, and many more!)Work-life balance with generous paid time offTuition reimbursementPersonal career and skill development opportunitiesWellness ProgramEmployee Assistance Program (EAP)Dedicated and passionate co-workers
We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Pay Rate:
Unspecified
HR. Website URL:
https://jobs.jobvite.com/lifenethealth/search?l=&c=
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About LifeNet Health
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue bank in the United States, as well as a leading innovator in transplantation research and regenerative medicine. LifeNet holds the longest running current accreditation by the American Association of Tissue Banks (AATB). Its goal is to improve the quality of human life through the provision of organs and tissues for transplantation, as well as innovation in the fields of bio-implants and regenerative medicine, and to serve the community with educational and support services that enhance the donation process.
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