Regulatory Affairs Specialist
Company: Jacaranda Consulting Inc.
Posted on: November 22, 2022
Provide support for new product development and transform the
on-market product development documentation in alignment with the
latest regulatory requirements.
Focus on improvement of the technical files and risk management
documentation including reviewing product/manufacturing process
changes, supplier changes, new and revised engineering protocols,
and reports, and reviewing product labeling.
Ensure compliance with the design control process and with the
Quality Management System.
Mentor more junior Regulatory employees.
The position will work closely with the R&D/Engineering group
as well as QA/RA.
BS or BE in a relevant science or engineering discipline.
Must possess knowledge of domestic (FDA) and foreign regulatory
requirements for the manufacture and distribution of medical
devices (especially design control and technical file
Must be able to meet deadlines, prioritize work, take the
initiative to follow-up on outstanding issues, complete assigned
tasks, handle multiple tasks, and work independently.
Able to communicate effectively (verbal and written) with internal
and external customers, and third-party registrar.
Job Type: Full-time
Pay: From $95,976.00 per year
* Health insurance
* Life insurance
* Vision insurance
* 8 hour shift
* Monday to Friday
Supplemental pay types:
* Bonus pay
Ability to commute/relocate:
* Billerica, MA: Reliably commute or planning to relocate before
starting work (Required)
* FDA regulations: 3 years (Preferred)
* Regulatory requirements for medical devices: 1 year
Work Location: One location%58047475%
Keywords: Jacaranda Consulting Inc., Billerica , Regulatory Affairs Specialist, Other , Billerica, Massachusetts
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