Regulatory Affairs Specialist

3 weeks ago

Saint Paul, United States Select Source International Full time
Job DescriptionJob Description

Job Title: Regulatory Affairs Specialist

Location: St. Paul, MN 55117

Job Type:  100% Onsite

Duration: 6 Months Contract

  • This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.
  • Provides regulatory affairs project management for various areas, to include regulatory submissions for new products, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.
  • Co-ordinates preparation of well organized, complete and scientifically sound regulatory submissions. Interfaces directly with various regulatory agencies, as required, to facilitate the timely review and approval of regulatory applications. Responsible for filing necessary applications and handling government interactions pertaining to the regulation process for products requiring regulatory approval.
  • Provides guidance on regulatory requirements and strategies to product development project teams. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises judgement within generally defined practices and departmental standard operating procedures.
  • Maintain expert working knowledge of relevant laws, regulations and enforcement decisions.
  • Knowledge of EU MDR requirements and other applicable EU regulations as they relate to Class III implantable medical devices. Authors and submits clinical trial applications under EUMDR and applications for CE mark. Proven successful track record of authoring/submission/approval of Class III implantable devices in EU.
  • Authors and submits IDE and PMA submissions, as well as supplements (5-Day Notice, 30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports etc.). Knowledge of FDA guidance documents and CFR regulations.
  • Working knowledge of regulatory requirements for Japan, Canada, and other countries is advantageous.
  • Reviews/approves engineering study protocols/reports and validation study protocols/reports. Reviews and approves manufacturing changes for Class III implantable medical devices.
  • Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Reports to head of a unit/department.

For this position it will be necessary to bring:

  • Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience.
  • Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA and EU MDR submissions for Class III medical devices.
  • Ability to work effectively on project teams. Ability to leverage and/or engage others to accomplish projects
  • Must be able to juggle multiple and competing priorities.
  • Strong written, verbal, presentation, and organizational skills.
  • Working knowledge of QSR, ISO, and EN standards.
  • Strong organizational skills and attention to detail.
  • Experience reviewing manufacturing operations and changes (change control).
  • Solid communication skills and ability to communicate at all levels.
  • Ability to think laterally and adapt to change.
Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

  • Senior Regulatory Affairs Specialist

    6 days ago

    Saint Paul, Minnesota, United States Collabera Full time

    Job DescriptionDetailed Summary:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for performing assigned regulatory activities, including submissions/responses to country authorities.In this role, you will plan and prepare documents for EU MDR...

  • Regulatory Affairs Specialist

    1 week ago

    Saint Paul, Minnesota, United States Volt Full time

    Job SummaryVolt is hiring a Hybrid Regulatory Affairs Coordinator in Maplewood, MN. This role involves investigating and maintaining regulatory product certification claims data, databases, and documentation systems. The ideal candidate will have a technical background and experience in quality assurance.The position requires ensuring accurate data entries,...

  • Regulatory Affairs Specialist

    6 days ago

    Saint Paul, Minnesota, United States Collabera Full time

    Job SummaryThis role involves leading project submissions for regulatory approvals and acting independently to identify and resolve problems. The ideal candidate will have advanced regulatory expertise, strategic thinking, and creativity in support of programs.Key ResponsibilitiesLead project submissions for regulatory approvalsApply advanced regulatory...

  • Regulatory Operations Specialist I

    3 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global leader in healthcare, dedicated to improving lives through innovative medical technologies and treatments.Job OverviewWe are seeking a highly skilled Regulatory Operations Specialist I to join our team in St. Paul, MN. As a key member of our Regulatory Affairs department, you will play a critical role...

  • Regulatory Affairs Expert with EU MDR Compliance

    4 weeks ago

    Saint Paul, Minnesota, United States Collabera Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Collabera. In this role, you will be responsible for performing regulatory activities including submissions/responses to country authorities.

  • Senior Regulatory Affairs Specialist

    3 months ago

    Saint Paul, United States Collabera Full time

    Job DescriptionJob Description·         Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use:·         Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files...

  • Regulatory Affairs Operations Specialist I

    3 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    Discover a rewarding career at Abbott Laboratories, a global leader in healthcare innovation. We are seeking a highly skilled Regulatory Affairs Operations Specialist I to join our team in St. Paul, MN.

  • Regulatory Affairs Director

    1 week ago

    Saint Paul, Minnesota, United States Collabera Full time

    Job SummaryWe are seeking a highly experienced Regulatory Affairs Manager to lead project submissions for regulatory approvals and drive strategic thinking in support of programs. This role will be responsible for applying advanced regulatory expertise, guiding cross-functional partners, and developing regulatory strategies.About the Role:Leverage extensive...

  • Regulatory Affairs Officer

    1 week ago

    Saint Paul, Minnesota, United States State of Minnesota Full time

    **Role Description**The Regulatory Affairs Officer will play a key role in ensuring the health and safety of Minnesota citizens by investigating complaints against licensees and registrants. As a member of the Board of Cosmetologist Examiners, you will be responsible for conducting investigations, collecting evidence, and preparing written reports.**Key...

  • Director of Regulatory Affairs- Strategy

    3 weeks ago

    Saint Paul, MN, United States Beacon Hill Staffing Group, LLC Full time

    Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Summary of Position The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and/or authoring compliant content for new and existing dossiers,...

  • Regulatory Affairs Manager

    2 weeks ago

    St Paul, United States Intellectt Inc Full time

    Role: Regulatory Affairs ManagerLocation: St. Paul, MN - 55117Duration: 6+ Months Shift Timings: 8 AM to 5 PMKey Responsibilities: Leadership & Regulatory Expertise:Lead and manage regulatory submissions for Class III medical devices (IDE, PMA, CE Mark, and clinical trial applications).Develop and execute regulatory strategies to ensure timely approvals in...

  • Regulatory Affairs Manager

    2 days ago

    St Paul, United States TalentBurst, an Inc 5000 company Full time

    Regulatory Affairs ManagerSt. Paul MN6 MonthsRegulatory Affairs Project Manager (Individual Contributor Role)This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in...

  • Regulatory Affairs Manager

    3 days ago

    St Paul, United States TalentBurst, an Inc 5000 company Full time

    Regulatory Affairs ManagerSt. Paul MN6 MonthsRegulatory Affairs Project Manager (Individual Contributor Role)This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in...

  • Regulatory Affairs Manager

    2 weeks ago

    St Paul, United States TalentBurst, an Inc 5000 company Full time

    Regulatory Affairs ManagerSt. Paul MN6 MonthsRegulatory Affairs Project Manager (Individual Contributor Role)This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in...

  • Regulatory Affairs

    3 weeks ago

    Saint Louis, United States Randstad Full time

    Job DescriptionJob DescriptionImmediate opportunity for a Regulatory Affairs / Document Specialist. As the selected candidate, you will have the opportunity to work with a global leader in agricultural research. This is a hybrid position that requires the selected candidate work part of the week onsite in St. Louis, MO. Relocation cost reimbursement is not...

  • Regulatory Affairs Specialist

    3 weeks ago

    Saint Louis, United States Randstad Full time

    Job DescriptionJob DescriptionExciting opportunity in St. Louis, MO for a Regulatory Affairs Specialist! Join a global leader in agricultural research. Immediate hire available. Explore the world of crop science and regulatory affairs.This is a hybrid position located in St. Louis, MO. Local candidates are preferred as relocation cost reimbursement is not...

  • Regulatory Affairs Director

    3 weeks ago

    Saint Paul, Minnesota, United States Sumitomo Pharma Full time

    Transforming Global Regulatory StrategySUMITOMO PHARMA America, a global pharmaceutical leader, is seeking an accomplished Director of Regulatory Affairs to spearhead our advanced therapeutic solutions in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With a diverse pipeline of early- to late-stage...

  • Regulatory Operations Specialist I

    4 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    Abbott Laboratories is a leading healthcare company that offers diverse opportunities for growth and development. Our team of professionals works together to deliver innovative solutions that improve people's lives.We are seeking a Regulatory Operations Specialist I to join our St. Paul, MN location. As a member of our team, you will be responsible for...

  • Director, Regulatory Affairs

    3 weeks ago

    Saint Paul, MN, United States Sumitomo Pharma Full time

    Sumitomo Pharma Director, Regulatory Affairs Saint Paul, Minnesota Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology,...

  • Regulatory Affairs Manager

    2 weeks ago

    St Paul, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    Job Title: Regulatory Affairs ManagerSite/Location: St. Paul, MN 55117 (100% Onsite)Duration: 6 Months Contract on W2 from your start dateShift Time: 08:00 AM - 5:00 PM (Flexible)Pay Rate: $47.00/hr. on W2. Job DescriptionThis position leads project submissions for regulatory approvals and acts independently to identify and resolve problems.Applies advanced...