186574 - Regulatory Affairs Specialist II
Industry
PRO
Region
MA-Massachusetts
City
Remote
State
Rate
$DOE
Duration
5 Months
Description
Chipton-Ross is seeking a Regulatory Affairs Specialist II for a remote opening.

RESPONSIBILITIES:
Prepare, compile and publish electronic pre-market and post-market regulatory submissions
Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark Interact with business partners to support WW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
Develop and execute submission strategies for assigned projects.
Monitor progress on key project deliverables and provide status updates on regular basis.
Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance Develop and/or revise regulatory procedures

REQUIRED EXPERIENCE:
Demonstrated ability to coordinate complex projects.
Strong oral and written communication and presentation skills
Solid working knowledge of the US Regulations and European IVD and medical device directives
Good analytical and problem-solving skills.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Experience with International submissions and IVDs highly desirable Capacity to communicate regulations to technical functions within the company
Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
Solid computer skills in Microsoft Office
International RA experience preferred or a minimum of 1-year direct experience in Regulatory Affairs within the IVD Industry

PREFERRED EXPERIENCE:
Understanding of FDA and European Medical device and IVD regulations.
Working knowledge of the medical device product lifecycle.
Product design and manufacturing change assessments for regulatory reporting.
International regulations and submissions

EDUCATION:
Accredited Bachelor’s degree required in the life sciences or engineering with a minimum of 2 – 4 years direct experience in Regulatory Affairs (within an IVD industry preferred).

WORK HOURS:
1st Shift
Full-Time

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.