ClevelandRecruiter Since 2001
the smart solution for Cleveland jobs

Regulatory Specialist

Company: Job Juncture
Location: Mentor
Posted on: October 14, 2019

Job Description:

Job Summary
The Regulatory Affairs Associate is an integral part of the Quality and Regulatory team. The associate will be responsible for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analyzing data, reporting trends, and coordinating CAPA facilitation. In addition, the specialist will provide regulatory support to product development, quality, and production with respect to design, process, and quality concerns.
--
Essential Skills:
Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.
Evaluates the local and global regulatory environment and assists in providing strategies throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance and prevent any regulatory obstacles.
Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies.
Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in all markets.
Evaluates regulatory classification and provides regulatory direction to product development team during design and development.
Develops and evaluates risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets.
Provides regulatory information and guidance for proposed product claims/labeling
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
Assists other departments in the development of SOPs to ensure regulatory compliance.
Reviews proposed product changes for impact on regulatory status of the product.
Responsible for maintenance, and improvement of Training module of the Document Control system compliant with FDA and ISO requirements.
Prepare/record changes to controlled documents including formatting, review and confirm changes with relevant departments, prepare training material, and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective.
Ensure documents and records meet quality standards and maintain onsite and offsite document storage.
Analyzes data, tracks and trends quality metrics, and develops solutions as needed for management review.
Complies with regulatory requirements of the FDA, Health Canada, European Union, Japan, and any other regulations of target markets.
Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory compliance.
Excellent written and verbal communication skills, and able to utilize Adobe, Microsoft power point, Excel and Microsoft Word effectively
Performs other duties that are reasonably assigned
--
Job Requirements:


  • A Bachelor's degree in a scientific discipline is required.
  • Regulatory affairs experience in a medical device environment and comprehensive understanding of applicable FDA and ISO regulations with RAPS/RAC certification is preferred.
  • Travel - Estimated travel is less than 20%, on an as-needed basis

Keywords: Job Juncture, Cleveland , Regulatory Specialist, Other , Mentor, Ohio

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


CDL-A Lease Purchase Truck Driver - *$2500 SIGN ON BONUS* Take Home $1200-$1700 or More a Week!
Description: CALL TO TALK TO A RECRUITER TODAY 888 893-5464 Have you ever dreamed of owning your truck and being your boss Come experience the many reasons why Western Express is the best place to realize those (more...)
Company: Western Express
Location: Mansfield
Posted on: 10/15/2019

CDL-A Flatbed Owner Operator Truck Driver
Description: CDL-A OTR OWNER OPERATOR TRUCK DRIVER JOBSGrow Your CDL-A Business With Flatbed, Step Deck Heavy Haul Routes At Bennett Motor Express, we know there s nothing more important than family. In fact, our (more...)
Company: Bennett Motor Express
Location: Mansfield
Posted on: 10/15/2019

CDL-A Company Drivers Refrigerated Regional
Description: Opportunities Available for COMPANY DRIVERSBenefits ul li 1,100 a week li Consistent freight li Weekly home time li Pay Accelerators earn up to 8 cents MORE per mile for your
Company: Roehl Transport
Location: Mansfield
Posted on: 10/15/2019


KFC Team Member
Description: If you need assistance in the application or hiring process to accommodate a disability, you may request an accommodation at any time by contacting the location nearest you. KFC Team Member 1447 Lexington (more...)
Company: StaffAttract
Location: Mansfield
Posted on: 10/15/2019

URGENT: Babysitting Wanted - Mansfield Caretaker Opportunity, Seeking Sitter
Description: Hi there my name is Ashley.
Company: Sitter
Location: Mansfield
Posted on: 10/15/2019

CDL-A OTR Dry Van Truck Driver - Earn $75K a Year or More!
Description: Western Express is now hiring in your area. Whether you're an experienced driver or you're just starting your career, Western Express
Company: Western Express
Location: Mansfield
Posted on: 10/15/2019

CDL-A Flatbed Truck Driver Earn up to $85K a Year!
Description: Western Express is hiring CDL -A truck drivers of ALL levels of experience. If necessary, we will pay you to train with some of our best team members in
Company: Western Express
Location: Mansfield
Posted on: 10/15/2019

General Transcriber
Description: Individuals who can transcribe audio content of financial results conferences, medical training seminars, group project meetings and other general business meetings.
Company: Mommy Jobs Online
Location: Youngstown
Posted on: 10/15/2019

Crew Member
Description: This job opportunity is with one of our many franchisees. Independently owned and operated, Wendy's franchise organizations
Company: Wendy's
Location: Mansfield
Posted on: 10/15/2019

Healthcare - internet/phone req.
Description: Our company is seeking outgoing, energetic people who have a passion for helping others work
Company: Ameriplan
Location: Youngstown
Posted on: 10/15/2019

Log In or Create An Account

Get the latest Ohio jobs by following @recnetOH on Twitter!

Cleveland RSS job feeds