Regulatory Affairs Specialist jobs in Elkhart, IN

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist-EIS : Medical Device & Regulations
  • TEPHRA
  • Warsaw, IN FULL_TIME
  • Description :

    The candidates will work with client & Our Client's teams to deliver best in-class solutions for regulatory submissions. Assist in the creation of technical documentation (technical files and design dossiers) for Spine products that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.

    The requirement is for 3 Regulatory Affairs Specialist.

    Responsibilities :

    • Identify reference documents for technical documentation including, but not limited to design and risk documents, verification / validation documents, standards conformance, and labeling.
    • Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
    • Provide support for Clinical Evaluation Reports including references to required documentation.
    • Align technical documentation according to OneMD technical documentation structure proposed by the MDR team.
    • Prepare technical documentation for submission to and reviewed by Notified Bodies, as required.
    • Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
    • Maintain information on worldwide regulatory requirements and the status of product registrations.
    • Be responsible for adherence to timelines and ensure milestones are achieved.
    • Report issues to the Customer and Our client management to ensure appropriate closure.
    • Work with Our Client teams at offshore and at other geographies.

    Qualifications :

    Experience Required :

    • Strong knowledge of EU Medical Device regulations and guidance documents as well as relevant standards.
    • Experience of Tech File and technical Documentation for submission to notified bodies
    • Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labelling, Sterility, Medical and Clinical.
    • Experience in working with PLM systems (i.e. Agile and Windchill)
    • Proficient with MS Office applications such as MS Word, Excel.
    • Excellent communication and inter-personal skills.
    • Ability to manage multiple tasks and be detail-oriented.
    • Knowledge of German is a plus

    Generic Managerial Skills :

    • Highly developed negotiation and influencing skills
    • Highly developed and proven written and oral communication skills
    • Organizational / planning skills
    • Strong analytical skills
    • Comfortable with using and facilitating a variety of problem solving methodologies
    • Mentors and develops junior staff within the our Client's delivery organization
    • Willing to work with offshore teams in remote locations

    Education :

    Bachelor of Engineering (Mechanical, Biomedical preferred) or Bachelor of Science (Biology or Chemistry)

    1 day ago
  • 21 Days Ago

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Sourcing Specialist
  • Dexter Axle
  • Elkhart, IN OTHER
  • Overview Dexter, the premier manufacturer and supplier of axles, suspension, brakes, doors, venting products, trailer parts, accessories, and towing components serving the commercial trailer, RV, heav...
  • 10 Days Ago

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Payroll Specialist
  • Brinkley RV
  • Goshen, IN FULL_TIME
  • DescriptionBrinkley RV is seeking a highly motivated Payroll Specialist to join our team. The ideal candidate will have a strong background in payroll processing and be able to work in a fast-paced en...
  • 10 Days Ago

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Collections Specialist
  • Lake City Bank
  • Warsaw, IN FULL_TIME
  • Starting Pay: $18.00 (pay is reviewed after 90 days)Are you a customer-service oriented individual interested in working behind the scenes for a company that cares about your future? Do you like to se...
  • 12 Days Ago

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Product Specialist
  • Impact Solutions Inc
  • Warsaw, IN FULL_TIME
  • Now Hiring: Product Specialist Location: Warsaw, IN area What You’ll Do: As the Product Specialist, you'll play a crucial role in providing technical information and training to customers. You'll spen...
  • 13 Days Ago

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Sourcing Specialist
  • Dexter Axle
  • Elkhart, IN OTHER
  • Overview Dexter, the premier manufacturer and supplier of axles, suspension, brakes, doors, venting products, trailer parts, accessories, and towing components serving the commercial trailer, RV, heav...
  • 13 Days Ago

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0 Regulatory Affairs Specialist jobs found in Elkhart, IN area

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EHS Manager
  • Lippert Components
  • Elkhart, IN
  • Overview Who We Are: Lippert is a leading, global manufacturer and supplier of highly engineered products and customized...
  • 3/19/2024 12:00:00 AM

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Radiology Technologist
  • Beacon Health System
  • Elkhart, IN
  • Part-time 3301 County Road 6 East Radiology Services Day Reports to the Practice Manager. Operates basic x-ray equipment...
  • 3/18/2024 12:00:00 AM

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Health, Safety, and Environmental Manager
  • Selmer Co., Inc.
  • Elkhart, IN
  • Apply Description Reports to: Senior Director of Manufacturing and Distribution Responsible for developing, managing, mo...
  • 3/18/2024 12:00:00 AM

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Medical Assistant
  • Beacon Health System
  • Elkhart, IN
  • Full-time 1001 Parkway Avenue Nursing Support Day Reports to the Practice Manager and works under the direction of the C...
  • 3/18/2024 12:00:00 AM

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Real Estate Buyer's Agent
  • Cressy & Everett Real Estate
  • Elkhart, IN
  • Job Description A Real Estate Buyer's Agent is a real estate agent who helps clients with their home purchasing needs. Y...
  • 3/15/2024 12:00:00 AM

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Real Estate Sales Representative
  • Cressy & Everett Real Estate
  • Elkhart, IN
  • Job Description A Real Estate Sales Representative is a real estate agent who meets with clients to help them with the p...
  • 3/15/2024 12:00:00 AM

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Real Estate Agent -- No Experience Necessary
  • Cressy & Everett Real Estate
  • Elkhart, IN
  • Job Description A Real Estate Agent is responsible for helping clients with every aspect of the real estate transaction ...
  • 3/15/2024 12:00:00 AM

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Asset protection team leader
  • Meijer, Inc.
  • Elkhart, IN
  • As a family company, we serve people and communities. When you work at Meijer, you're provided with career and community...
  • 3/15/2024 12:00:00 AM

Elkhart /ˈɛlkɑːrt/ is a city in Elkhart County, Indiana, United States. The city is located 15 miles (24 km) east of South Bend, Indiana, 110 miles (180 km) east of Chicago, Illinois, and 150 miles (240 km) north of Indianapolis, Indiana. Elkhart has the larger population of the two principal cities of the Elkhart-Goshen Metropolitan Statistical Area, which in turn is part of the South Bend-Elkhart-Mishawaka Combined Statistical Area, in a region commonly known as Michiana. The population was 50,949 at the 2010 census. Despite the shared name, it is not the county seat of Elkhart County; that ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,172 to $96,720
Elkhart, Indiana area prices
were up 1.3% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020