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Medical Device Regulatory Affairs Specialist

Synkriom

Warsaw, Indiana • Today

Easy Apply

Contract

Depends on Experience

Regulatory Affairs Specialist

NexInfo Solutions, Inc.

Remote • 11d ago

Easy Apply

Contract, Third Party

$60 - $70

Regulatory Specialist

Trinite Consulting Group LLC

Remote • 4d ago

Easy Apply

Contract

Depends on Experience

Regulatory Affairs Data Coordinator

Motion Recruitment Partners, LLC

Remote or Irvine, California • Today

Easy Apply

Contract

Regulatory Specialist

Motion Recruitment Partners, LLC

Remote or Raynham, Massachusetts • Today

Easy Apply

Contract

Regulatory Affairs Specialist Small Molecule

Jean Martin, Inc

Remote • 8d ago

Easy Apply

Contract, Third Party

Depends on Experience

Field Service Engineer II (Medical Devices) - Northwest Regional Float

Boston Scientific Corporation

Remote or Maple Grove, Minnesota • Today

Full-time

USD 49,608.00 - 84,344.00 per year

Clinical Research Specialist

Motion Recruitment Partners, LLC

Remote or Irvine, California • Today

Easy Apply

Contract

Senior Account Manager- Medical Devices

Celestica International LP

Remote • Today

Full-time

USD 123,000.00 - 163,000.00 per year

Senior Director, AI & Data Science Solutions

Otsuka Pharmaceutical Co., Ltd.

Remote • Today

Full-time

USD 230,720.00 - 345,000.00 per year

Medical Device V&V engineers

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

Full-time

AWS Solutions Architect - Certified

Alkaeus

Remote • 14d ago

Easy Apply

Full-time, Third Party

$60 - $70

SAP Delivery Manager (ERP) Life Sciences

Devfi

Remote • 29d ago

Easy Apply

Contract

Depends on Experience

Systems Design Engineer 4

DivIHN Integration Inc.

Remote • 5d ago

Easy Apply

Third Party, Contract

$71 - $75

Job Details

Skills

Conflict Resolution
Distribution
Regulatory Compliance
Writing
Supervision
Storage
Research
Relationship Building
Regulatory Affairs
Promotions
Medical Devices
Advertising
Attention To Detail
Negotiations
Assembly
Life Sciences
Communication
Microsoft Office
Multitasking
Problem Solving
Gas cabinates
vacuum system

Summary

JOB DESCRIPTION:

Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.

Respond to requests from foreign government and/or distributors as needed

Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Evaluate risk of proposed regulatory strategies; may offer solutions

Reviews proposed labeling for compliance with applicable global regulations

Writes and manages the development of package inserts

Reviews and evaluations promotion and advertising material for compliance with applicable regulations

Reviews proposed product changes for impact on regulatory status of the product

Communicates with regulatory and governmental agencies with supervision

Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams

Skills:

Strong writing, communication, and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of overall business environment, the orthopaedic industry, and the marketplace
Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
Knowledge of FDA, EU, and other regulatory body regulations
Ability to identify risk in Regulatory strategies
Strong problem solving skills
Effective negotiating skills

Basic computer skills, including Microsoft Office Suite

Education:

Bachelor s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
A minimum of one year of experience in orthopaedic or medical device industry preferred
A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
Regulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90944144
Position Id: 9065975
Posted 8 hours ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Contact the job poster

Sumanth Parikh

Recruiter @ Synkriom

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Regulatory Specialist

Remote

•

4d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

Easy Apply

Contract

Depends on Experience

Regulatory Affairs Specialist

Remote

•

11d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as invent

Easy Apply

Contract, Third Party

$60 - $70

US Regulatory Lead

Remote

•

Today

Key Responsibilities & Skills US FDA Regulatory Requirements IND / NDA / BLA Submission Management Regulatory Research & Intelligence Cross-Functional Team Representation Process Mapping & Authoring for Submissions External Innovation Assessment (Regulatory) Oncology & Neurology Therapeutic Knowledge Project Deliverable Coordination Regulatory Strategy Development US Regulatory Compliance Technical Skills eCTD / FDA Submission Portal Regulatory Intelligence Tools Document Management Systems Educ

Contract

Depends on Experience

QUALITY ENGINEER

Hybrid in Chicago, Illinois

•

4d ago

MAJOR RESPONSIBILITIES: Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Lead investigations of product and process non-conformances and out-of-specification results and develop ef

Easy Apply

Contract

Depends on Experience

Job Details

Skills

Conflict Resolution
Distribution
Regulatory Compliance
Writing
Supervision
Storage
Research
Relationship Building
Regulatory Affairs
Promotions
Medical Devices
Advertising
Attention To Detail
Negotiations
Assembly
Life Sciences
Communication
Microsoft Office
Multitasking
Problem Solving
Gas cabinates
vacuum system

Summary

JOB DESCRIPTION:

Respond to requests from foreign government and/or distributors as needed

Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Evaluate risk of proposed regulatory strategies; may offer solutions

Reviews proposed labeling for compliance with applicable global regulations

Writes and manages the development of package inserts

Reviews and evaluations promotion and advertising material for compliance with applicable regulations

Reviews proposed product changes for impact on regulatory status of the product

Communicates with regulatory and governmental agencies with supervision

Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams

Skills:

Strong writing, communication, and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of overall business environment, the orthopaedic industry, and the marketplace
Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
Knowledge of FDA, EU, and other regulatory body regulations
Ability to identify risk in Regulatory strategies
Strong problem solving skills
Effective negotiating skills

Basic computer skills, including Microsoft Office Suite

Education:

Bachelor s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
A minimum of one year of experience in orthopaedic or medical device industry preferred
A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
Regulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered

Dice Id: 90944144
Position Id: 9065975
Posted 8 hours ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Contact the job poster

Sumanth Parikh

Recruiter @ Synkriom

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Regulatory Specialist

Remote

•

4d ago

Easy Apply

Contract

Depends on Experience

Regulatory Affairs Specialist

Remote

•

11d ago

Easy Apply

Contract, Third Party

$60 - $70

US Regulatory Lead

Remote

•

Today

Contract

Depends on Experience

QUALITY ENGINEER

Hybrid in Chicago, Illinois

•

4d ago

Easy Apply

Contract

Depends on Experience