MILLENNIUMSOFT
Join to apply for the
Regulatory Affairs Specialist
role at
MillenniumSoft Inc Join to apply for the
Regulatory Affairs Specialist
role at
MillenniumSoft Inc Position : Regulatory Affairs Specialist
Location : San Jose, CA
Category : Professional
Type : Temporary
No Of Positions:1
Duration : 12+ Month(s) Contract
Start Time : 8:00 AM
End Time : 5:00 PM
Total Hours/week : 40.00
Education: Required Bachelors Degree
Qualifications
MINIMUM QUALIFICATIONS
A minimum of a Bachelor's of Science degree. A minimum of 2 years experience working in a medical device environment. A minimum of 2 years prior experience working on product regulatory submissions. KNOWLEDGE AND SKILLS. The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology. Individuals who have obtained a Regulatory Certification are a plus Previous experience working for a medical device manufacturer. Knowledge of regulations related to product lasers. Experience with flow cytometry, hematology, and/or immunoassay are a plus. Orientation for detail work product, with emphasis on accuracy and completeness. Effective written and oral communication skills. Good organizational and planning skills; drives for results. Effective analytical/problem solving skills. Good interpersonal skills that involves working well in a team environment and the ability to lead others. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. Working knowledge of project management and design control. Ability to identify areas of concern in moderately complex projects and manage change. Computer literacy (PC, Microsoft Word/Excel/PowerPoint) EDUCATION AND EXPERIENCE Typically requires a BA/BS degree in Chemistry, Biology, Engineering, or Medical Technology and three years of related experience, or equivalent combination of related education and experience.
Responsibilities
Responsible for the preparation and documentation of regulatory submissions to government agencies. Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. DUTIES AND RESPONSIBILITIES
With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues. Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents. Acts as a liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups. Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance. 5. Direct certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests. Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements. Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system. Brings Regulatory Affairs questions/issues to the attention of RA management. Preparing responses to agencys questions with good writing and communication skills. Performs other related duties and assignments as required.
Salary: $30.00-$40.00
Seniority level
Seniority level
Entry level Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Regulatory Affairs Specialist jobs in
San Jose, CA . San Jose, CA $80,000.00-$90,000.00 4 months ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)
Union City, CA $100,000.00-$120,000.00 2 hours ago Sunnyvale, CA $80,900.00-$128,800.00 9 hours ago Milpitas, CA $115,000.00-$150,000.00 2 weeks ago Regulatory Affairs Specialist I - Heart Failure (on-site)
Pleasanton, CA $72,100.00-$114,700.00 1 week ago San Jose, CA $172,000.00-$234,000.00 1 hour ago Sr Regulatory Affairs Specialist (Remote) - Shockwave
Regulatory Affairs Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 1 week ago Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Senior Regulatory Affairs Specialist -Vascular (on-site)
Senior Regulatory Affairs Specialist Vascular (on-site)
Global Privacy Counsel, Regulatory Investigations
San Jose, CA $140,000.00-$240,000.00 4 days ago Sr Regulatory Affairs Specialist - Shockwave Medical
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Union City, CA $100,000.00-$120,000.00 1 hour ago Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
Sunnyvale, CA $80,000.00-$140,000.00 7 months ago Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp
Santa Clara, CA $89,000.00-$165,600.00 5 days ago Program Quality & Compliance Specialist I
Regulatory Affairs Manager Vascular (on-site)
Regulatory Affairs Manager Heart Failure (on-site)
Pleasanton, CA $112,000.00-$224,000.00 2 days ago Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
Sunnyvale, CA $119,900.00-$203,000.00 11 hours ago Senior Regulatory Affairs Specialist - Investigational Device Exemption (IDE)
Sunnyvale, CA $119,900.00-$203,000.00 9 hours ago Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (on-site)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs Specialist
role at
MillenniumSoft Inc Join to apply for the
Regulatory Affairs Specialist
role at
MillenniumSoft Inc Position : Regulatory Affairs Specialist
Location : San Jose, CA
Category : Professional
Type : Temporary
No Of Positions:1
Duration : 12+ Month(s) Contract
Start Time : 8:00 AM
End Time : 5:00 PM
Total Hours/week : 40.00
Education: Required Bachelors Degree
Qualifications
MINIMUM QUALIFICATIONS
A minimum of a Bachelor's of Science degree. A minimum of 2 years experience working in a medical device environment. A minimum of 2 years prior experience working on product regulatory submissions. KNOWLEDGE AND SKILLS. The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology. Individuals who have obtained a Regulatory Certification are a plus Previous experience working for a medical device manufacturer. Knowledge of regulations related to product lasers. Experience with flow cytometry, hematology, and/or immunoassay are a plus. Orientation for detail work product, with emphasis on accuracy and completeness. Effective written and oral communication skills. Good organizational and planning skills; drives for results. Effective analytical/problem solving skills. Good interpersonal skills that involves working well in a team environment and the ability to lead others. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. Working knowledge of project management and design control. Ability to identify areas of concern in moderately complex projects and manage change. Computer literacy (PC, Microsoft Word/Excel/PowerPoint) EDUCATION AND EXPERIENCE Typically requires a BA/BS degree in Chemistry, Biology, Engineering, or Medical Technology and three years of related experience, or equivalent combination of related education and experience.
Responsibilities
Responsible for the preparation and documentation of regulatory submissions to government agencies. Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. DUTIES AND RESPONSIBILITIES
With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues. Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents. Acts as a liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups. Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance. 5. Direct certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests. Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements. Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system. Brings Regulatory Affairs questions/issues to the attention of RA management. Preparing responses to agencys questions with good writing and communication skills. Performs other related duties and assignments as required.
Salary: $30.00-$40.00
Seniority level
Seniority level
Entry level Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Regulatory Affairs Specialist jobs in
San Jose, CA . San Jose, CA $80,000.00-$90,000.00 4 months ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)
Union City, CA $100,000.00-$120,000.00 2 hours ago Sunnyvale, CA $80,900.00-$128,800.00 9 hours ago Milpitas, CA $115,000.00-$150,000.00 2 weeks ago Regulatory Affairs Specialist I - Heart Failure (on-site)
Pleasanton, CA $72,100.00-$114,700.00 1 week ago San Jose, CA $172,000.00-$234,000.00 1 hour ago Sr Regulatory Affairs Specialist (Remote) - Shockwave
Regulatory Affairs Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 1 week ago Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Senior Regulatory Affairs Specialist -Vascular (on-site)
Senior Regulatory Affairs Specialist Vascular (on-site)
Global Privacy Counsel, Regulatory Investigations
San Jose, CA $140,000.00-$240,000.00 4 days ago Sr Regulatory Affairs Specialist - Shockwave Medical
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Union City, CA $100,000.00-$120,000.00 1 hour ago Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
Sunnyvale, CA $80,000.00-$140,000.00 7 months ago Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp
Santa Clara, CA $89,000.00-$165,600.00 5 days ago Program Quality & Compliance Specialist I
Regulatory Affairs Manager Vascular (on-site)
Regulatory Affairs Manager Heart Failure (on-site)
Pleasanton, CA $112,000.00-$224,000.00 2 days ago Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
Sunnyvale, CA $119,900.00-$203,000.00 11 hours ago Senior Regulatory Affairs Specialist - Investigational Device Exemption (IDE)
Sunnyvale, CA $119,900.00-$203,000.00 9 hours ago Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (on-site)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr