Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Parsippany, NJ
View more jobs in New Jersey

Job Details

Regulatory Affairs Specialist

Location
Parsippany, NJ, United States

Posted on
Feb 10,2020

Apply for this job






Profile

Job Description:
Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services.
Summary: The Market Access Specialist is responsible for regulatory submission activities as well as maintaining regulatory support for existing in vitro diagnostic products. The Specialist leads or assists in the preparation, review, filing and control of regulatory documents.
Essential Duties & Responsibilities:
Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities, including the collection and organization of information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
Create and maintain an electronic or hard copy filing system for organizational records, regulatory submission documents, etc.
Ensure archived material is properly categorized and accessible.
Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. Procure and organize reference materials from various sources including peer-reviewed scientific journals, government publications, and reputable websites.
Evaluate research data, put together presentations for management with recommendations, and maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
Identifies the need for new regulatory procedures and SOPs, and leads development and implementation of such.
Continually improves the quality of policies, programs and services provided.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Evaluates the regulatory environment and provides internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Provides, as required, regulatory input and approval for changes and classification of changes to DHF, DMR and QS records/documentation.
Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Evaluates proposed products for regulatory classification and jurisdiction.
Maintains information systems (electronic and paper) for regulatory information and reports and ensures compliance with Quality System regulations.
Reviews and edits complex technical documents for clarity, grammar, spelling, punctuation and consistency in English.
Ensures that the clinical and nonclinical data--in conjunction with regulatory strategy--are consistent with the regulatory requirements and support the proposed product claims.
Maintain FURLS listings and support the provision of CFGs.
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Education & Requirements:
Bachelor's degree required in Sciences or Engineering. Advanced degree a plus. Focus in Biology, Chemistry, Mechanical Engineering, or Computer Science preferred.
At least three years of applicable work experience, two if directly related to in vitro diagnostic products.
Ability to operate the Microsoft suite of products (excel, powerpoint, project) and Adobe Acrobat.
RAC certification (U.S. and/or devices) preferred
up to 10%, including international travel.
Skills:
Fluent in English and have excellent written and verbal communication skills.
Demonstrated ability to provide information used to evaluate proposed products for regulatory classification and jurisdiction.
Understands scientific and health principles related to healthcare product development and regulations.
Proven to anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
An ability to work co-operatively and effectively with others to establish and maintain strong working relationships with team members both locally and internationally.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Apply Now
Summary: The Market Access Specialist is responsible for regulatory submission activities as well as maintaining regulatory support for existing in vitro diagnostic products. The Specialist leads or assists in the preparation, review, filing and control of regulatory documents. Essential Duties & Responsibilities: Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities, including the collection and organization of information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
Create and maintain an electronic or hard copy filing system for organizational records, regulatory submission documents, etc.
Ensure archived material is properly categorized and accessible.
Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. Procure and organize reference materials from various sources including peer-reviewed scientific journals, government publications, and reputable websites.
Evaluate research data, put together presentations for management with recommendations, and maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
Identifies the need for new regulatory procedures and SOPs, and leads development and implementation of such.
Continually improves the quality of policies, programs and services provided.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Evaluates the regulatory environment and provides internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Provides, as required, regulatory input and approval for changes and classification of changes to DHF, DMR and QS records/documentation.
Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Evaluates proposed products for regulatory classification and jurisdiction.
Maintains information systems (electronic and paper) for regulatory information and reports and ensures compliance with Quality System regulations.
Reviews and edits complex technical documents for clarity, grammar, spelling, punctuation and consistency in English.
Ensures that the clinical and nonclinical data--in conjunction with regulatory strategy--are consistent with the regulatory requirements and support the proposed product claims.
Maintain FURLS listings and support the provision of CFGs.
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Education & Requirements: Bachelor's degree required in Sciences or Engineering. Advanced degree a plus. Focus in Biology, Chemistry, Mechanical Engineering, or Computer Science preferred.
At least three years of applicable work experience, two if directly related to in vitro diagnostic products.
Ability to operate the Microsoft suite of products (excel, powerpoint, project) and Adobe Acrobat.
RAC certification (U.S. and/or devices) preferred
up to 10%, including international travel.
Skills: Fluent in English and have excellent written and verbal communication skills.
Demonstrated ability to provide information used to evaluate proposed products for regulatory classification and jurisdiction.
Understands scientific and health principles related to healthcare product development and regulations.
Proven to anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
An ability to work co-operatively and effectively with others to establish and maintain strong working relationships with team members both locally and internationally.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.

Company info

Sign Up Now - ChemistryCrossing.com

Similar Jobs:
Documentation Specialist
Location : Somerville, NJ
1 year contract\n$30.00 - $35.00\nMust sit onsite in Branchburg, NJ\nBachelor's degree in Chemistry, Biological Sciences, Business Administration or a related field, or an equivalent combination of education and work experience\nA...
SchrŲdingerís mission is to revolutionize drug discovery through the use of breakthrough computational methods.† We deploy these methods both through software sales and by using them to advance our own internal drug discovery effo...
Chemical Engineer
Location : Picatinny Arsenal, NJ
About the Position: The Combat Capabilities Development Command (CCDC) Armaments Center is the Army's Center of Lethality, and provides more than 90 percent of the Army's lethality to soldiers. CCDC Armaments Center mission includ...