Regulatory Affairs Specialist II

4 weeks ago


Chaska, United States TalentBurst Full time
Regulatory Affairs Specialist II
Chaska, MN 55318
Duration: 12 month(s)

Description/Comment: Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs
Support the IA business units in meeting global registration requirements
As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies
Investigates and resolves compliance problems, questions and complaints
Ensures timely preparation of organized and scientifically valid reports both internally and externally - Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements
- - Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence
- Prepares and maintains regulatory licenses, reports, and listings
Minimum qualifications: -: 3-5 YEARS EXPERIENCE IN DIAGNOSTIC REGULATORY AFFAIRS IVD / IVDR KNOWLEDGE, GLOBAL REGISTRATIONS (EU, CANADA, BRAZIL, LATIN AMERICA, ASIA Client
Bachelors degree in sciences, engineering, or technical field and 5 years of relevant experience or a Masters degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level
Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs
- Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields
Previous regulatory experience desirable
- Ability to prioritize assigned work
- Ability to learn regulatory procedures
- Ability to communicate accurately with internal and external contacts
- Ability to work with team members to resolve problems and achieve goals
- Experience with LEAN principles desirable
- Experience with risk management (FMEA/HHA) desirable
- RAC desired.
#TB_PH

  • Chaska, United States Sunrise Systems Full time

    Job Title: Regulatory Affairs Specialist II OnSite @Chaska location Mon-Fri 8 to 5 7:30 AM to 4:30 PM - Flexible Duration: 12 months on Contract Skills required for this position: 1. Regulatory experience in Medical Device Industry i.e Post Market Activities; field actions (recalls), supporting international registrations, and design change...


  • chaska, United States TalentBurst Full time

    Regulatory Affairs Specialist II Chaska, MN 55318 Duration: 12 month(s) Description/Comment: Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programsSupport the IA business units in meeting global registration requirementsAs a regulatory process expert supporting global registrations the...


  • Chaska, United States Net2Source Inc. Full time

    Job Title: Regulatory Affairs Specialist IILocation: Chaska MN 55318Duration:12+ Month ContractMon-Fri 8 to 5/Flex 7:30 AM to 4:30 PMPOSITION SUMMARY The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process...


  • Chaska, Minnesota, United States Compunnel Inc. Full time

    We are seeking a skilled Regulatory Affairs Specialist to join our team at Compunnel Inc. in the biotechnology industry. This 12-month contract is 100% onsite, Monday to Friday, with a pay rate of $30 to $33 per hour on a W2 basis, without benefits.The ideal candidate will have 3-5 years of experience in diagnostic regulatory affairs, with knowledge of...


  • Chaska, Minnesota, United States Sunrise Systems Full time

    At Sunrise Systems, we are seeking a skilled Regulatory Affairs Specialist II to join our team. This is a 12-month contract position, working on-site at our Chaska location. The ideal candidate will have a strong background in medical device regulatory affairs, with experience in post-market activities, field actions, international registrations, and design...


  • Chaska, United States Compunnel Inc. Full time

    We are hiring for our client in the biotechnology industry.Duration: 12 months contractJob Type: 100% onsite; Monday to FridayPay rate: $30 to 33/hr on W2 (no benefits)Responsibilities:Coordinate and manage post-market regulatory reporting and compliance activities in accordance with company procedures and regulatory requirements.Support business units in...


  • Chaska, MN, United States Compunnel Inc. Full time

    We are hiring for our client in the biotechnology industry.Duration: 12 months contractJob Type: 100% onsite; Monday to FridayPay rate: $30 to 33/hr on W2 (no benefits)Responsibilities:Coordinate and manage post-market regulatory reporting and compliance activities in accordance with company procedures and regulatory requirements.Support business units in...

  • Program Supervisor II

    1 month ago


    Chaska, Minnesota, United States Mt Olivet Rolling Acres Full time

    Job Title: Program Supervisor IIAt Mt Olivet Rolling Acres, we are seeking a highly skilled and dedicated Program Supervisor II to join our team. As a key member of our leadership team, you will be responsible for the development, implementation, and monitoring of individual program plans for our clients. This role requires strong leadership and supervision...

  • EHS Program Manager

    1 month ago


    Chaska, Minnesota, United States Entegris Full time

    Job Overview:Job Summary:The Environmental Health and Safety (EHS) Specialist will be responsible for developing, implementing, and executing EHS programs and procedures to ensure compliance with regulatory requirements and industry best practices. This role will also focus on environmental compliance and hazardous waste management.Key...

  • EHS Specialist

    5 months ago


    Chaska, United States Entegris Full time

    Job Description: Summary:  The Environmental Health and Safety (EHS) Specialist is responsible for developing, implementing, and executing EHS programs and procedures along with continuously assessing performance through audits and inspections to verify comprehension of Entegris global policies, regulatory requirements, and industry best practices. ...


  • Chaska, Minnesota, United States Continental Engineering & Manufacturing, Inc (CEM) Full time

    Job SummaryCandidates will perform all maintenance, repairs, and preventative maintenance functions for all CNC and manual mills and lathes machines, building, equipment, and grounds.This role includes routine inspections and repair or replacement of machines, equipment, and the building's operating system.Key ResponsibilitiesRepairs to shop equipment,...


  • Chaska, Minnesota, United States STG International Full time

    Job Title: Weekend PT APRN Physician AssistantSTGi is currently seeking a Weekend PT APRN Physician Assistant to provide services at our Community Based Outpatient Clinic.Job Summary:The Weekend PT APRN Physician Assistant will provide professional clinical services under the direction of the Community Based Outpatient Clinic (CBOC) Primary Care Provider...


  • Chaska, United States STG International Full time

    STGi is currently seeking a weekend schedule PT Nurse Practitioner (NP) or Physician Assistant (PA) to provide services at our Community Based Outpatient Clinic. The general duty of the Nurse Practitioner (NP) or Physician Assistant (PA) is to provide professional clinical services under the direction of the Community Based Outpatient Clinic (CBOC) Primary...