Regulatory Affairs Manager jobs in Elkhart, IN

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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
  • 1 Month Ago

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Part Time Regulatory Compliance Administrator
  • Instrumedical Technologies, Inc.
  • Warsaw, IN PART_TIME
  • Company Overview:Instru-Med is a leading contract manufacturer operating in accordance with ISO 13485 standards. We specialize in providing high-quality manufacturing solutions for medical devices. Ou...
  • 3 Days Ago

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Manager
  • Hacienda Mexican Restaurants
  • Goshen, IN FULL_TIME
  • FullTime Manager Vacancy working for Hacienda Mexican Restaurants at Goshen IN
  • 25 Days Ago

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Manager
  • Subway - 2466-0
  • Elkhart, IN FULL_TIME
  • As part of the Subway® Team, you as a Manager will focus on eight main things: Providing an excellent guest experience Ensuring that great food is prepared & servedKeeping our restaurants functional, ...
  • 25 Days Ago

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Manager
  • Jimmy John's
  • Three Rivers, MI FULL_TIME
  • General Managers - $55k-$75k - bonus paid every 4 weeks - Locations in Paw Paw, Three Rivers, Kalamazoo/Portage. Tell us which location works best for youGeneral Managers oversee the day-to-day operat...
  • Just Posted

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Manager
  • Indiana
  • Elkhart, IN FULL_TIME
  • As part of the Subway® Team, you as a Manager will focus on eight main things : Providing an excellent guest experience Ensuring that great food is prepared & served Keeping our restaurants functional...
  • 3 Days Ago

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0 Regulatory Affairs Manager jobs found in Elkhart, IN area

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Remote Software Architect, Medical Device Industry, Unique Stable Comp
  • Medical Tech Company Focused on Improving Healthcare Outcomes
  • Elkhart, IN
  • Job Description Job Description Remote Role: Unique U.S. Based Company, Recession Resistant Niche Industry Client Base. ...
  • 3/28/2024 12:00:00 AM

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Surgical Physician Assistant or Nurse Practitioner
  • Beacon Health System
  • South Bend, IN
  • Full-time 100 Navarre Place Nursing Day Reports clinically to the Practice Site Physician(s) and administratively to the...
  • 3/28/2024 12:00:00 AM

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Nurse Practitioner Specialty Care
  • Beacon Health System
  • Elkhart, IN
  • Full-time 600 East Blvd. Nursing Day Reports to a Practice Manager/Director for administrative supervision and the Pract...
  • 3/28/2024 12:00:00 AM

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On-Call Surgery Registered Nurse
  • Beacon Health System
  • Elkhart, IN
  • Full-time 600 East Boulevard Nursing Night Open Heart OR Experience Required Reports to the Director. Provides professio...
  • 3/28/2024 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...
  • 3/28/2024 12:00:00 AM

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Microbiologist, 1st Shift
  • Voyant Beauty
  • Elkhart, IN
  • POSITION: Microbiologist PREREQUISITES: Bachelor's Degree in Microbiology or strong chemical background experience Stabl...
  • 3/27/2024 12:00:00 AM

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R&D Lab Chemist
  • HR Collaboration Group LLC
  • Elkhart, IN
  • R&D Lab Chemist This role is located in the Michiana, IN area. Want to be a part of an employee focused company who care...
  • 3/26/2024 12:00:00 AM

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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...
  • 3/24/2024 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 Manager jobs
$130,986 to $184,753
Elkhart, Indiana area prices
were up 1.3% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020