Sr Regulatory Affairs Specialist -771

Company: Infosoft
Location: Irvine
Posted on: November 26, 2022

Job Description:

One of our clients is looking for a talented and highly motivated *Sr Specialist, Regulatory Affairs*. Please *send your resume* if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are job position details for your review:

Job Title: *Sr Regulatory Affairs Specialist*
Pay Rate: $45 to 51/Hr
Duration: *12 Months *
Location: *Orange County, CA (First 3 weeks onsite and thereafter Hybrid with 1-2 days/week onsite)*

Our Client is a *Global Medical Device Manufacturer.*

We are looking for a *Regulatory Affairs Specialist* to support the Regulatory Intelligence program to help identify and meet Regulatory changes as early as possible that may impact business globally through:

* Creating strategies and contingency planning with respect to worldwide *Regulatory requirements*, including assessing the impact of proposed and current global regulations and proposing solutions for expediting approvals
* Creating gap assessments for changes in regulations/standards (Japan and UK)
* Providing guidance on the implementation of various Regulatory process improvement projects and collaborating directly with key stakeholders in all business units and functional groups as well as international counterparts to accelerate market access routes and ensure compliance
* Guide Business Unit RA teams based on Regulatory changes and compliance timelines
* Facilitate and/or lead teleconference and in-person meetings with key stakeholders of various positions including international partners
* The candidate must be comfortable speaking in meetings.
* Provide guidance on process improvement/remediation projects based on prior experience and responses from international affiliates
* Provide support to supervisor as needed.

*Skills: *

* Expertise in utilizing Microsoft Office Suite including Word, PowerPoint, and Excel to support highly-effective presentations, reporting, communications, assessments, etc.
* Experience in *giving presentations* to a wide group of stakeholders.
* Comfortable with *video calls*
* Proficiency in *hosting, presenting,* and troubleshooting *teleconferences* via *Microsoft Teams* including professional camera presence
* Effective written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills
* Strong problem-solving, organizational, analytical, and critical thinking skills
* Manage competing priorities in a fast-paced environment
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Build and sustain stable working relationships internally
* Must be able to work in a team environment, including immediate supervisor and other team members
* Competently conduct responsibilities in an office and/or home environment without close supervision required

*Education/Experience: *

* Bachelor's degree required; scientific discipline preferred
* Minimum five years of *Regulatory Affairs experience.* Medical device experience preferred
* Good knowledge and understanding of *global regulations* relevant to medical devices (e.g. product registration, UDI, labeling) from health authorities including FDA, NMPA, MHRA, and EU Commission. Asia Pacific regulations knowledge is preferred
* Good knowledge and understanding of global Regulatory requirements for new products or product changes
* Good knowledge of new product development systems

Job Types: Contract, Full-time

Salary: $45.00 - $51.00 per hour

Schedule:
* 8 hour shift
* Day shift
* Monday to Friday

Ability to commute/relocate:
* Irvine, CA: Reliably commute or planning to relocate before starting work (Required)

Education:
* Bachelor's (Preferred)

Experience:
* FDA regulations: 2 years (Required)

Work Location: One location%58047475%

Keywords: Infosoft, Irvine , Sr Regulatory Affairs Specialist -771, Other , Irvine, California