Regulatory Affairs Specialist
Company Name:
RCM Technologies
Reference # : 14-02134 Title : Regulatory Affairs Specialist
Location : Warsaw, IN
Position Type : Contract
Experience Level : 3 Years Start Date / End Date : 09/22/2014 / 09/23/2015
Description
Responsible for assisting the team with regulatory filings as necessary to market the client products.
This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an intermediate understanding of the client products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervision.
Specific Experience
5
years of Regulatory Affairs experience within Medical Device design and manufacturing environment is a must
Experience with device design controls and Design History Files (DHF) is a must
Thorough understanding of 510k submissions, their triggers and applicable regulations, is strongly preferred
Preparation of submissions to the FDA is strongly preferred
Pre-market regulatory experience is strongly preferred
Duties and Responsibilities
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
Reviews proposed labeling for compliance with applicable US and international regulations
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Evaluate risk of proposed regulatory strategies; may offer solutions
Writes/manages the development of package inserts.
Expected Areas of Competence
Demonstrated strong writing and communication skills
Strong attention to detail, ability to multi-task
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
Ability to function well as a member of the team and build relationships between RA and other areas of the organization
Able to identify risk in Regulatory strategies
Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
Basic computer skills, including Microsoft Office Suite
Education / Experience
USBachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
5
years of experience in Regulatory Affairs
Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US
Regulatory Affairs Certification (US or EU) preferredEstimated Salary: $20 to $28 per hour based on qualifications.
RCM Technologies
Reference # : 14-02134 Title : Regulatory Affairs Specialist
Location : Warsaw, IN
Position Type : Contract
Experience Level : 3 Years Start Date / End Date : 09/22/2014 / 09/23/2015
Description
Responsible for assisting the team with regulatory filings as necessary to market the client products.
This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an intermediate understanding of the client products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervision.
Specific Experience
5
years of Regulatory Affairs experience within Medical Device design and manufacturing environment is a must
Experience with device design controls and Design History Files (DHF) is a must
Thorough understanding of 510k submissions, their triggers and applicable regulations, is strongly preferred
Preparation of submissions to the FDA is strongly preferred
Pre-market regulatory experience is strongly preferred
Duties and Responsibilities
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
Reviews proposed labeling for compliance with applicable US and international regulations
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Evaluate risk of proposed regulatory strategies; may offer solutions
Writes/manages the development of package inserts.
Expected Areas of Competence
Demonstrated strong writing and communication skills
Strong attention to detail, ability to multi-task
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
Ability to function well as a member of the team and build relationships between RA and other areas of the organization
Able to identify risk in Regulatory strategies
Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
Basic computer skills, including Microsoft Office Suite
Education / Experience
USBachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
5
years of experience in Regulatory Affairs
Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US
Regulatory Affairs Certification (US or EU) preferredEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
