Regulatory Affairs Specialist
Company Name:
Career Transitions, LLC
Our client, a leading orthopedic company in Warsaw, IN is looking for a Regulatory Affairs Specialist for a 1 year contract.
Job Summary
Responsible for assisting the team with regulatory filings to market products. This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA).
Duties and Responsibilities
Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Reviews proposed labeling for compliance with applicable US and international regulations
Writes package inserts
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Expected Areas of Competence
Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
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 US and international regulations
Writes/manages the development of package inserts.
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Education/ Experience Requirements
US Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
Two to four years' experience in Regulatory Affairs
Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
egulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered
Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
Estimated Salary: $20 to $28 per hour based on qualifications.
Career Transitions, LLC
Our client, a leading orthopedic company in Warsaw, IN is looking for a Regulatory Affairs Specialist for a 1 year contract.
Job Summary
Responsible for assisting the team with regulatory filings to market products. This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA).
Duties and Responsibilities
Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Reviews proposed labeling for compliance with applicable US and international regulations
Writes package inserts
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Expected Areas of Competence
Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
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 US and international regulations
Writes/manages the development of package inserts.
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Education/ Experience Requirements
US Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
Two to four years' experience in Regulatory Affairs
Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
egulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered
Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
Estimated Salary: $20 to $28 per hour based on qualifications.
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