24 month contract with possible conversion to permanent employment after 1 year if desired.

Work is onsite w/ hybrid opportunity out of Moundsview MN- must reside within commutable distance.

• Directs or performs 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

QUALIFICATIONS:

• Bachelors degree and 7 years of Regulatory Affairs experience
• US/EU Submission experience
• Advertising and promotional regulatory Assessment experience
• Change controls experience

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

Job Type: Contract

Pay: $60.00 - $70.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Referral program
• Vision insurance

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs: 7 years (Required)
• US/EU Submission: 3 years (Required)
• Change controls: 3 years (Required)
• Advertising and promotional regulatory Assessment: 2 years (Required)

Ability to Relocate:

• Saint Paul, MN 55112: Relocate before starting work (Required)

Work Location: Hybrid remote in Saint Paul, MN 55112