Advanced IVD Regulatory Affairs Specialist - OEM Products
Bio-Techne
9 hours ago
Remote friendly (Minneapolis, MN)
United States
$62,300 - $102,350 USD yearly
Corporate Functions
Position Summary
Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Ensure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files. Perform additional duties as assigned.
Essential Functions
- Works in the regulatory affairs department on assigned projects.
- Maintain regulatory files.
- Coordinates with product development and/or R&D teams to request, develop, and prepare required data and reports for submission to regulatory bodies and agencies.
- Collaborates with key staff from Planning, Product Development, Operations, and Legal as required.
- Review and approve documents, labels, and other documentation.
- Assist with design control activities.
- Assist in Risk Management activities.
- Follows company policies and safety guidelines in accordance with the job.
- Perform additional duties as assigned.
Education and Experience
- Bachelor’s degree with 2–4 years of relevant experience.
- Or Master’s degree with up to 3 years of relevant experience.
Knowledge, Skills, and Abilities
- Attention to detail and organizational skills.
- Working knowledge of Microsoft Word and Excel.
- Computer entry, typing, or electronic document filing skills.
- Able to work in a fast-paced environment with multitasking.
- Excellent verbal and written communication skills.
- Knowledge of technical, regulatory, quality, and production management systems.
- Knowledge of documentation principles and processes.
- Accuracy, clarity, proofreading, and problem-solving skills.
- Knowledge of global regulations associated with in-vitro diagnostics.
- Technical document writing skills.
Benefits
- Competitive insurance benefits starting on day one (medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield).
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
- Accrued leave policy with paid holidays, paid time off, and paid parental leave.
Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Ensure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files. Perform additional duties as assigned.
Essential Functions
- Works in the regulatory affairs department on assigned projects.
- Maintain regulatory files.
- Coordinates with product development and/or R&D teams to request, develop, and prepare required data and reports for submission to regulatory bodies and agencies.
- Collaborates with key staff from Planning, Product Development, Operations, and Legal as required.
- Review and approve documents, labels, and other documentation.
- Assist with design control activities.
- Assist in Risk Management activities.
- Follows company policies and safety guidelines in accordance with the job.
- Perform additional duties as assigned.
Education and Experience
- Bachelor’s degree with 2–4 years of relevant experience.
- Or Master’s degree with up to 3 years of relevant experience.
Knowledge, Skills, and Abilities
- Attention to detail and organizational skills.
- Working knowledge of Microsoft Word and Excel.
- Computer entry, typing, or electronic document filing skills.
- Able to work in a fast-paced environment with multitasking.
- Excellent verbal and written communication skills.
- Knowledge of technical, regulatory, quality, and production management systems.
- Knowledge of documentation principles and processes.
- Accuracy, clarity, proofreading, and problem-solving skills.
- Knowledge of global regulations associated with in-vitro diagnostics.
- Technical document writing skills.
Benefits
- Competitive insurance benefits starting on day one (medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield).
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
- Accrued leave policy with paid holidays, paid time off, and paid parental leave.