Synergy Solutions
Sr. Regulatory Affairs Specialist
Synergy Solutions, Minneapolis, Minnesota, United States, 55400
24 month contract with possible conversion to permanent employment.
Mounds View location - Hybrid- 3 days in the office.
Responsibilities:
Performs authoring, coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking/control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Supports change management activities with sense of urgency to provide solid regulatory assessment for changes during product lifecycle.
Qualifications:
BS Degree and 5 years of experience.
Post-market change regulatory assessment experience: 30 days.
Annual Report memo authoring.
RTR submissions and site transfer submission experience.
Able to work well and collaborate cross-functionally to complete change management activities.
Job Type:Contract
Pay:$45.00 - $55.00 per hour
Expected hours:40 per week
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Required)
Experience:
Medical Device Regulatory Affairs: 5 years (Required)
Post-market change regulatory assessment: 2 years (Required)
Annual Report memo authoring: 2 years (Required)
RTR submissions and site transfer submission: 1 year (Required)
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled.
The Company will consider qualified applicants with arrest and conviction records.
Work Location: In person
#J-18808-Ljbffr
Mounds View location - Hybrid- 3 days in the office.
Responsibilities:
Performs authoring, coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking/control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Supports change management activities with sense of urgency to provide solid regulatory assessment for changes during product lifecycle.
Qualifications:
BS Degree and 5 years of experience.
Post-market change regulatory assessment experience: 30 days.
Annual Report memo authoring.
RTR submissions and site transfer submission experience.
Able to work well and collaborate cross-functionally to complete change management activities.
Job Type:Contract
Pay:$45.00 - $55.00 per hour
Expected hours:40 per week
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Required)
Experience:
Medical Device Regulatory Affairs: 5 years (Required)
Post-market change regulatory assessment: 2 years (Required)
Annual Report memo authoring: 2 years (Required)
RTR submissions and site transfer submission: 1 year (Required)
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled.
The Company will consider qualified applicants with arrest and conviction records.
Work Location: In person
#J-18808-Ljbffr