What are the responsibilities and job description for the Regulatory Affairs Specialist (510 K/submission/medical device) position at Rangam Consultants Inc.?
2 years regulatory experience and/or 2 years relevent industrial experience typically with a quality, product-development/support, or scientific affairs function
Skills:
- Knoweldge of regulations and standards affecting IVDs and/or biologics
Education:
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
Duties:
- Regulatory experience in IVD (Software as a medical device preferably)
- 510 K or CE Mark submissions and reviewing and approving Ad Promo Materials.
- Assist in the preparation and submission of applications for renewal and for registration of new products and variations to marketed products.
- Ensure completeness of product registration dossiers per product regulatory classification.
- Prepare risk analysis and mitigation strategies of any new/upcoming regulations or requirements for business.
- To review and approve ad Promo materials.
Intake notes:
Does this role have potential to extend and/or convert? Yes, it has a potential to be extended or to convert in a permanent employee. expected to be 1 year contract
What are the top 3-5 qualifications you are looking for in resumes?
- Regulatory experience in IVD (Software as a medical device preferably)
- This might sound weird, but based on my previous experience I highly inquire that the person knows how to handled Microsoft programs, Word, excel, PP, etc.
- 510 K or CE Mark submissions and reviewing and approving Ad Promo Materials.
What are the top 3-5 responsibilities of this role?
- Prepare risk analysis and mitigation strategies of any new/upcoming regulations or requirements for business.
- Assist in the preparation and submission of applications for renewal and for registration of new products and variations to marketed products.
- Ensure completeness of product registration dossiers per product regulatory classification.
- To review and approve ad Promo materials.
Job Types: Full-time, Contract
Salary: $20.00 - $38.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Lake Forest, IL 60045: Reliably commute or planning to relocate before starting work (Preferred)
Education:
- Bachelor's (Preferred)
Experience:
- regulatory affairs: 2 years (Preferred)
- medical device industry: 2 years (Preferred)
- 510 K or CE Mark submissions: 2 years (Preferred)
- Regulatory submissions: 2 years (Preferred)
- reviewing and approving Ad Promo Materials.: 2 years (Preferred)
Work Location: One location