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Sr. Regulatory Affairs Specialist

In Wisconsin / United States

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Sr. Regulatory Affairs Specialist   

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JOB TITLE:

Sr. Regulatory Affairs Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Madison Wisconsin / United States

JOB DESCRIPTION:

Job Title Sr. Regulatory Affairs Specialist

Location Madison, Wisconsin 53703

Duration 6 month

Description:

Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives for client business units, while ensuring compliance with US FDA and Health Canada Class I medical devices. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets in order to meet launch timelines.

Expectations:

Develop and implement US FDA and Health Canada medical device specific regulatory strategies in support of business objectives.

Monitor the development of regulatory initiatives and communicate potential business impact to business and QRC senior management.

Provide interpretation on and training of domestic and international regulatory requirements to the appropriate business and QRC team members.

Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective actions.

Scope:

The incumbent is responsible for establishing and maintaining regulatory strategies designed to effectively and efficiently support business objectives.

This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business (es).

The main challenges of the position are:

Understanding the various domestic and international business needs.

Understanding and interpreting domestic and international regulations relative to new technology, and product development.

Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the business units.

Have the insight to problem-solve proactively on regulatory and associated quality issues.

Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.

Comply with policies, internal controls and global regulations.

Qualifications/Education/Experience Required:

A broad technical background is required; a bachelor's degree in a major scientific discipline and 7 to10 years of relevant technical experience. Must possess an understanding of US FDA and Health Pre-market Notification and clearance process, product development process including product design/formulation, manufacturing, engineering, marketing and legal matters obtained through experience and/or advanced education and the implications on a global launch of a given product.

Position Details

POSTED:

Sep 05, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864351792625

LOCATION:

Wisconsin / United States

CITY:

Madison

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Sr. Regulatory Affairs Specialist    Apply

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Job Title Sr. Regulatory Affairs Specialist

Location Madison, Wisconsin 53703

Duration 6 month

Description:

Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives for client business units, while ensuring compliance with US FDA and Health Canada Class I medical devices. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets in order to meet launch timelines.

Expectations:

Develop and implement US FDA and Health Canada medical device specific regulatory strategies in support of business objectives.

Monitor the development of regulatory initiatives and communicate potential business impact to business and QRC senior management.

Provide interpretation on and training of domestic and international regulatory requirements to the appropriate business and QRC team members.

Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective actions.

Scope:

The incumbent is responsible for establishing and maintaining regulatory strategies designed to effectively and efficiently support business objectives.

This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business (es).

The main challenges of the position are:

Understanding the various domestic and international business needs.

Understanding and interpreting domestic and international regulations relative to new technology, and product development.

Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the business units.

Have the insight to problem-solve proactively on regulatory and associated quality issues.

Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.

Comply with policies, internal controls and global regulations.

Qualifications/Education/Experience Required:

A broad technical background is required; a bachelor's degree in a major scientific discipline and 7 to10 years of relevant technical experience. Must possess an understanding of US FDA and Health Pre-market Notification and clearance process, product development process including product design/formulation, manufacturing, engineering, marketing and legal matters obtained through experience and/or advanced education and the implications on a global launch of a given product.


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