Current jobs related to Regulatory Affairs Specialist II - Plymouth - Abbott Laboratories

  • Regulatory Affairs Specialist

    2 weeks ago

    Plymouth, United States The Judge Group Full time

    Our client is currently seeking a Regulatory Affairs Specialist for a 12 month + contract. NOTE: THIS IS A HYDRID ROLE. 3 DAYS OF THE WEEK THE TEMP WILL BE REQUIRED TO WORK ONSITE. TEMP-PERM FOR THE RIGHT PERSON• Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures,...

  • Regulatory Affairs Specialist III

    2 months ago

    Plymouth, United States Integer Holdings Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success...

  • Senior Regulatory Affairs Specialist

    4 months ago

    Plymouth, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

  • Regulatory Affairs Coordinator

    4 weeks ago

    Plymouth, United States Zentis North America LLC Full time

    Regulatory Affairs Coordinator Zentis is Europe's number one fruit processing company and one of the leading brand manufacturers of jams, sweets and custard-based dessert. The Company's North American operations are located in Philadelphia, Pennsylvania and Plymouth, Indiana, where we produce fruit and dairy preparations for a variety of customers including...

  • Senior Director, Advertising and Promotion Regulatory Affairs

    2 weeks ago

    Plymouth Meeting, Pennsylvania, United States Organon Full time

    {"Responsibilities": "Lead the TeamAs the Senior Director, Advertising and Promotion Regulatory Affairs, you will lead a team of Advertising and Promotion reviewers responsible for review and approval of assigned projects. This may include products in all phases of development through registration and mature products.Key ResponsibilitiesLead the team...

  • Traveling MRI Imaging Specialist

    4 weeks ago

    Plymouth, Massachusetts, United States Infojini Healthcare II Full time

    Company: Infojini Healthcare IIPosition Overview:We are currently seeking a skilled Traveling MRI Imaging Specialist to join our team. This role involves providing high-quality imaging services in various healthcare settings.Key Responsibilities:Conduct all technical and mechanical aspects of Magnetic Resonance Imaging.Position patients effectively while...

  • National Director, Field Medical Affairs

    2 months ago

    Plymouth Meeting, United States Inovio Pharmaceuticals Full time

    Job DescriptionJob DescriptionAbout INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines in development are delivered using our proprietary smart device to produce immune responses against targeted...

  • MRI Technologist

    3 weeks ago

    Plymouth, Massachusetts, United States Infojini Healthcare II Full time

    Infojini Healthcare II is seeking a skilled MRI Technologist to join our team in a travel position.Job SummarySpecialty: MRI TechnologistDiscipline: Allied Health ProfessionalJob Type: TravelShift: 8 hours, flexibleHours per Week: 40Key Responsibilities:Perform all technical and mechanical aspects of Magnetic Resonance Imaging, including positioning and...

  • R-D Engineer II

    3 months ago

    Plymouth, United States ATR International Full time

    Job Description: We are seeking a R-D Engineer II for a very important client This role is within the Client's Peripheral Vascular Health organization’s Released Product Management R&D team The team covers a portfolio of devices that includes self-expanding stent, balloon expanding stents, drug and non-drug coated balloons, embolic protection,...

  • R&D Engineer II

    4 months ago

    Plymouth, United States Abbott Laboratories Full time

    Clinical Research & Development (R&D) Engineer II – Structural HeartPlymouth, MNTHIS IS AN ON-SITE DAILY POSITION.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can...

  • R&D Engineer II

    3 weeks ago

    Plymouth, United States Redbock - an NES Fircroft company Full time

    R&D Engineer II (12-month contract // Hybrid - Plymouth, MN):Candidate is expected to be on site 3 days per week Top Required Skills:R&D Experience in medical devices and the quality/regulatory processes around them, preferably for on-market/sustaining productsExperience developing regulatory strategy/updates, especially related to EU MDR complianceTM...

  • R&D Engineer II

    3 weeks ago

    Plymouth, United States Redbock - an NES Fircroft company Full time

    R&D Engineer II (12-month contract // Hybrid - Plymouth, MN):Candidate is expected to be on site 3 days per week Top Required Skills:R&D Experience in medical devices and the quality/regulatory processes around them, preferably for on-market/sustaining productsExperience developing regulatory strategy/updates, especially related to EU MDR complianceTM...

  • Water Treatment Plant Operator II

    3 weeks ago

    Plymouth, Massachusetts, United States American States Utility Services, Inc. Full time

    Job SummaryWe are seeking a highly skilled Water Treatment Plant Operator II to join our team at American States Utility Services, Inc. This is a critical role that requires a strong understanding of water treatment processes and a commitment to delivering high-quality services to our customers.Key ResponsibilitiesPerform routine inspections and monitoring...

  • Quality Assurance NDT Specialist

    4 weeks ago

    Plymouth, Michigan, United States LOC Performance Products, Inc. Full time

    Position OverviewLOC Performance Products, Inc. is dedicated to delivering comprehensive solutions for intricate mechanical products and engineered systems. Our operations encompass a wide range of services, from initial design to prototype development, testing, production initiation, and ongoing product support. We pride ourselves on providing high-quality...

  • Technician II, Extrusion-Second Shift

    2 months ago

    Plymouth, United States Abbott Full time

    The Opportunity As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. This position works out of our Plymouth , MN location in the Cardiac Rhythm Management division. We are seeking a high caliber Technician II,...

  • Extrusion Manufacturing Engineer II

    1 month ago

    Plymouth, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll...

  • Supplier Quality Engineer

    1 week ago

    Plymouth, United States Intellectt Inc Full time

    Job Title: Supplier Quality EngineerDuration: Plymouth, MNJob Summary:As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and compliance of materials and components sourced from suppliers. Your primary focus will be on developing, validating, and implementing test methods to evaluate supplier materials, ensuring they meet...

  • Supplier Quality Engineer

    1 week ago

    Plymouth, United States Intellectt Inc Full time

    Job Title: Supplier Quality EngineerDuration: Plymouth, MNJob Summary:As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and compliance of materials and components sourced from suppliers. Your primary focus will be on developing, validating, and implementing test methods to evaluate supplier materials, ensuring they meet...

  • Extrusion Manufacturing Engineer II

    2 months ago

    Plymouth, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Abbott is a...

  • Supplier Qual Engineer II

    4 months ago

    Plymouth, United States Artech LLC Full time

    Job Title : Supplier Qual Engineer IIJob ID : 14516Location : 2300 Berkshire Ln N, Ste 5, Plymouth, Minnesota, 55441 (Hybrid)Duration : 6 months JOB DESCRIPTIONAdditional position detail from the manager below - looking only for individuals with previous MDT experience as an SQE, that can be onsite and start ASAP.  This is a short-term need. Can you...

Regulatory Affairs Specialist II

4 months ago

Plymouth, United States Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

In Abbottâs Electrophysiology (EP) business, weâre advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN.  In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

What Youâll Work On

  • Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
  • Creates, reviews and approves engineering changes.
  • Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
  • Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
  • Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.  Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested. 
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • May interface directly with FDA and other regulatory agencies if so directed.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

  • Bachelorâs degree (or equivalent)
  • 2-3 yearsâ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.  
  • Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

  • Bachelorâs degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  
  • Proficient with MS Office suite (Word, Excel, Outlook)

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $57,300.00 â $114,700.00. In specific locations, the pay range may vary from the range posted.