Top 41 Regulatory affairs Jobs in Indiana

Regulatory Affairs Specialist
OrthoPediatrics —Warsaw, IN
- Full-time
- Anatomy knowledge
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Director MISO Regulatory Affairs
American Municipal Power, Inc —Carmel, IN
- Full-time
- Engineering
- Office
- Travel
Quick Apply
4d
Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy
Eli Lilly —Indianapolis, IN
- $169,500 - $248,600 a year
- Full-time
- Office
- Master's degree
- 8 years
- Health insurance
- Dental insurance
Clinical Research Coordinator
Indiana University —Indianapolis, IN
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- Accounting
- Paid parental leave
- Health savings account
Global Regulatory Project Manager
Corteva Agriscience —Indianapolis, IN
- Hybrid work
- Bachelor's degree
- Budgeting
- Senior level
- Paid holidays
- Health insurance
Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine
Eli Lilly —Indianapolis, IN
- $169,500 - $248,600 a year
- Full-time
- Master's degree
- 8 years
- Bachelor's degree
- Health insurance
- Dental insurance
Project Lead Data Manager
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Office
- Paid time off
- Parental leave
Sr. Director – Global Ethics & Compliance Officer
Eli Lilly —Indianapolis, IN
- $154,500 - $226,600 a year
- Full-time
- 3 years
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
11h
Mgr, Regulatory Labeling & Industry Engagement
Nutrien US LLC —Indiana
- $91,200 - $169,300 a year
- Full-time
- Background check
- Office
- Bachelor's degree
- Paid holidays
- Disability insurance
Research Advisor
Eli Lilly —Indianapolis, IN
- $148,500 - $257,400 a year
- Full-time
- 11+ years
- Analysis skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
5h
Feed Additive Regulatory Specialist
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Office
- Master's degree
- Paid time off
- Parental leave
Natural Resource Project Manager
State of Indiana —Indianapolis, IN
- From $67,314 a year
- Overtime
- 5 years
- Research
- No degree
- Free parking
- Paid parental leave
10d
Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides
Eli Lilly —Indianapolis, IN
- $148,500 - $257,400 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Manufacturing
- Health insurance
- Dental insurance
Clinical Research Technician
Indiana University —Indianapolis, IN
- $37,598.40 - $42,598.40 a year
- Full-time
- Hybrid work
- High school diploma or GED
- University
- 1 year
- Paid parental leave
- Health savings account
Clinical Research Coordinator, Neurological Surgery
Indiana University —Indianapolis, IN
- Full-time
- Surgery
- Mid-level
- Analysis skills
- Paid parental leave
- Health savings account
Data Reviewer, Quality Control Microbiology
Bristol-Myers Squibb —Indianapolis, IN
- $31.07 - $37.64 an hour
- Weekends as needed
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Paid holidays
- Disability insurance
11d
Sr Specialist, Regulatory - Fertilizer & Plant Nutrition
Nutrien Ag Solutions, Inc —Indiana
- $79,100 - $139,800 a year
- Full-time
- Background check
- 6 years
- Bachelor's degree
- Paid holidays
- Disability insurance
Advisor, Analytical Separations & Biochemistry, Analytical Development - BR&D
Eli Lilly —Indianapolis, IN
- $126,000 - $244,200 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Clinical Research Specialist
Indiana University —Indianapolis, IN
- $49,000 a year
- Full-time
- Spanish
- Mid-level
- Databases
- Paid parental leave
- Health savings account
10d
Lead Professional Affairs Specialist
CONMED —Indianapolis, IN
- $78,200 - $121,200 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Employee stock purchase plan
- Disability insurance
Quick Apply
10h

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Regulatory Affairs Specialist

OrthoPediatrics
Warsaw, IN

Quick Apply

Job Details

Full-time

Qualifications

Technical editing
Anatomy knowledge
Microsoft Excel
Content creation for technical audiences
Microsoft Outlook
Technical documentation
Copy machines
Basic math
Driver's License
Bachelor's degree
Fax machines
Faxing
Technical writing experience within technology
Grammar Experience
Medical terminology

Full Job Description

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

GENERAL SUMMARY: The Regulatory Affairs Specialist will act as regulatory representative on cross functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work closely with each project team to develop regulatory strategies, testing requirements and other documentations to assure that regulatory submissions are prepared and cleared/approved to meet the company's product launch timelines for new and modified products.

ESSENTIAL FUNCTIONS:

Work closely with each New Product Development team in developing the regulatory strategy for the new and modified products.
Work closely with the product managers to understand the country’s registration needs and priorities and provide regulatory input to the product managers such as registration strategies, timeline, and costs.
Work closely with engineering team on the testing requirements and support the development of verification and validation testing plan. Review engineering documentation under the design history file to ensure compliance with the standards, guidance, and regulatory requirements.
Prepare regulatory submissions such as 510(k), Letter to File, Health Canada Submission, Technical Files, etc. for new and modified devices.
Updates and maintains databases with required information and status for UDI, GUDID, licenses, approvals, renewals, and other required data to assure compliance with business and regulatory requirements.
Review and approve product, supplier, and manufacturing changes for compliance with applicable regulations and applicable procedures. Work closely with Regulatory and Clinical Affairs team members to provide regulatory change assessments for each country/region where the products are registered.
Work closely with Regulatory and Clinical Affairs team members in monitoring the impact of changing regulations of each country on submission requirements and strategies.
Assign, review, revise and approve device labeling and marketing materials to ensure continued compliance with global regulations.
Provide support in developing regulatory procedures when necessary.
Provide regulatory input for product recalls and recall communications.
Performs other duties as assigned.

SUPERVISORY RESPONSIBILITIES: There are no direct supervisory responsibilities for this position.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Demonstrate a fundamental understanding of medical device terminology, anatomy, regulations, standards and technical concepts
Understanding of regulations and guidelines governing all phases of Medical Device development with guidance and supervision.
Understanding new product development requirements and processes with guidance and supervision.
Excellent technical writing and editing skills, verbal and written communication skills including presentation skills.
Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities.
Able to work within deadlines as imposed by government regulations and internal guidelines.
Able to take direction and work and solve problems both independently and as part of a team.

EDUCATION AND/OR EXPERIENCE: Requires a bachelor’s degree; advanced degree preferred. Minimum of 2 years’ experience in regulatory of medical devices is preferred.

LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.

MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.

REASONING ABILITY: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver’s license.

OTHER SKILLS AND ABILITIES: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation will be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is that found in a normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel.

The above statement reflects the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.

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Refine Your Search

regulatory affairs jobs in indiana

Regulatory Affairs Specialist

Director MISO Regulatory Affairs

Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy

Clinical Research Coordinator

Global Regulatory Project Manager

Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Project Lead Data Manager

Sr. Director – Global Ethics & Compliance Officer

Mgr, Regulatory Labeling & Industry Engagement

Research Advisor

Feed Additive Regulatory Specialist

Natural Resource Project Manager

Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides

Clinical Research Technician

Clinical Research Coordinator, Neurological Surgery

Data Reviewer, Quality Control Microbiology

Sr Specialist, Regulatory - Fertilizer & Plant Nutrition

Advisor, Analytical Separations & Biochemistry, Analytical Development - BR&D

Clinical Research Specialist

Lead Professional Affairs Specialist

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