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Regulatory Affairs Specialist

Company: Jacaranda Consulting Inc.
Location: Billerica
Posted on: November 22, 2022

Job Description:

*Description: *

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 compilation).

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

* 401(k)
* 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 (Required)

Work Location: One location%58047475%

Keywords: Jacaranda Consulting Inc., Billerica , Regulatory Affairs Specialist, Other , Billerica, Massachusetts

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