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Regulatory Affairs Specialist - Labeling - Senior

Company: Artech LLC
Location: Remote
Posted on: November 27, 2022

Job Description:

Job Title: - Regulatory Affairs Specialist - Labeling - Senior

Location: Remote

Duration: 09 months



Description

EU MDR Senior RA Specialist Responsibilities:



Supports in the generation of Technical Files and Design Dossiers

Works with cross functional teams to deliver supporting documentation (IFU, DHF, CER etc.)

Supports and implements the global market change program

Demonstrates strong understanding of MDR requirements

Supports Technical File Audits

"Line Management of RA Associate



(10%) Assists with preparing and communicates submission/compliance strategy document

(10%) Reports compliance metrics to the RA Franchise lead/Manufacturer Lead and works with the RA Franchise lead/Manufacturer lead to plan and deliver submissions to specified timeframes.

(40%) Prepares and reviews technical documentation including labelling and instructions for use and works with relevant team to resolve issues. Post finalised technical documentation to central repository.

(30%) Communicates changes to global markets and provides submission deliverables.

(10%) Prepares for and assists with Notified Body technical audits; responds to any deficiencies



Location: Remote employee to support Austin x 1 site.

Education: Educated to Degree level, or equivalent professional experience

Experience:

Minimum: 3 years Regulatory experience within the Medical Device industry.

Good interpersonal/communication skills are essential.

Experience of providing Regulatory Advice to the business is essential.

Ability to handle multiple demands in a fast-paced environment.

Experience working with large and diverse groups. Strong understanding of EU medical device regulatory affairs preferred.

Competences: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills.





Dipeeka Kumari

Team Lead





Office: 973-863-3206

Email:



Website:



Keywords: Artech LLC, Eugene , Regulatory Affairs Specialist - Labeling - Senior, Other , Remote, Oregon

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