Associate II, Regulatory Affairs

1 month ago

Lake Forest, United States ICU Medical Full time
Description

Position Summary

Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.

Essential Duties & Responsibilities

•Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.

•Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.

•With oversight, understand and respond to regulatory agency correspondence.

•Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.

•Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.

•Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.

Knowledge & Skills

•Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.

•Identify registration documentation deficiencies and work with colleagues to accomplish resolution.

•Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.

•Prepare and maintain regulatory strategy with supervision.

•Exercise good judgment within policy and regulations.

•Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.

•Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.

•Presents scientific data effectively orally and in writing in a logical and persuasive manner.

•Provides daily regulatory support to new product development teams and commercial support with guidance.

•Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.

•Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management.

Minimum Qualifications, Education & Experience

•Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.

•RAC Certification preferred

•Three plus years of experience in Medical Products Industry with a minimum of 2 years of experience in Regulatory Affairs.

•Able to assess scientific arguments and apply analytical and logical reasonings.

•Ability to effectively prioritize workload and multitask with minimal supervision.

•Good interpersonal skills.

•Good oral and written communications skills.

•Demonstrated project management skills.

•Demonstrated critical thinking, contingency planning and negotiating skills.

•Understanding of regulatory and business needs with ability to engage cross functional team members.

•Must be at least 18 years of age

Work Environment

•This is largely a sedentary role.

•This job routinely uses standard office equipment.

•Typically requires travel less than 5% of the time

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

  • Regulatory Affairs Specialist II

    2 weeks ago

    Lake Forest, Illinois, United States ICU Medical Full time

    Position Overview The role involves providing essential regulatory support and direction related to the global and US registration of medical device products. This includes analyzing regulatory requirements and monitoring deliverables. Under supervision, the position aids in the implementation of global regulatory strategies and contributes to the...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Lake Forest, United States Abbott Laboratories Full time

    About AbbottDiagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Lake Forest, 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.About...

  • Regulatory Affairs Operations Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Experis Full time

    Our client, a prominent player in the Healthcare sector, is seeking a Regulatory Affairs Operations Specialist II. In this role, you will be tasked with executing intricate global regulatory strategies, securing and upholding marketing authorizations for products, and conveying essential regulatory requirements to facilitate the licensing of...

  • Regulatory Affairs Ops Specialist II

    4 weeks ago

    Round Lake, United States Experis Full time

    Our client, one of the largest Healthcare companies in the U.S., is looking for a Regulatory Affairs Ops Specialist II which is Round Lake, IL. As a Regulatory Specialist you will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory...

  • Regulatory Specialist II

    2 weeks ago

    Lake Forest, United States Collabera Full time $33 - $36

    Job DescriptionJob Description·         The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit.  ·         In this role you will prepare documentation for EU Technical Files and international product registrations.  ·         This job description will be reviewed periodically and is...

  • Regulatory Specialist II

    3 months ago

    Lake Forest, United States Collabera Full time

    Job DescriptionJob Description·         The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit.  ·         In this role you will prepare documentation for EU Technical Files and international product registrations.  ·         This job description will be reviewed periodically and is...

  • Regulatory Affairs Operations Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Experis Full time

    Position Overview:We are seeking a skilled Regulatory Affairs Operations Specialist II to support our healthcare initiatives. This role involves the execution of complex global regulatory strategies and the maintenance of marketing authorizations for various products.Key Responsibilities:Formulating and implementing intricate regulatory project...

  • Regulatory Compliance Specialist II

    2 weeks ago

    Lake Forest, Illinois, United States ICU Medical Full time

    Position Overview The role involves providing regulatory assistance and expertise related to the global and US registration of medical device products. This includes evaluating requirements and monitoring deliverables. Under supervision, the position supports the implementation of global regulatory strategies and aids in the development and upkeep of global...

  • Regulatory Affairs Manager

    2 weeks ago

    Salt Lake, Utah, United States ICU Medical Full time

    Position Overview The Regulatory Affairs Manager plays a crucial role in providing support and direction related to the global and US registration of medical device products. This position involves analyzing regulatory requirements and monitoring deliverables to ensure compliance. The manager will assist in the development and maintenance of...

  • Global Regulatory Affairs Specialist

    1 month ago

    Salt Lake City, United States USANA Health Sciences Full time

    Who We Are Looking For We are looking for a meticulousindividual to join USANA as a global regulatory affairs specialistto ensure compliance with domestic and international regulations across all assigned markets. In this role, you will be responsible for executing various regulatory affairs functions, maintaining the highest standards of procedural...

  • Senior Manager of Regulatory Affairs

    2 weeks ago

    Salt Lake, Utah, United States ICU Medical Full time

    Position Overview The Regulatory Affairs Manager plays a crucial role in ensuring compliance with global and US regulations related to medical device products. This position involves analyzing regulatory requirements and tracking deliverables to support the registration process. The manager will assist in the development and maintenance of comprehensive...

  • Lead Manager of Regulatory Affairs

    2 weeks ago

    Lake George, United States COV Covidien LP Full time

    Position OverviewAs a key member of the team at COV Covidien LP, you will embark on a fulfilling career dedicated to advancing healthcare solutions and ensuring equitable access to medical innovations.Role ResponsibilitiesIn the capacity of Senior Regulatory Affairs Manager, your primary focus will be to devise and implement strategies for global product...

  • Sr Specialist, Regulatory Affairs

    4 weeks ago

    Round Lake, United States Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Compliance Specialist

    2 weeks ago

    Lake Forest, California, United States Astrix Inc Full time

    Company Overview:Astrix Inc. is a prominent leader in the manufacturing of innovative eye care solutions and medical devices. We are currently seeking a Regulatory Affairs Specialist to enhance our dedicated team.Position Overview:As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with global regulations while supporting...

  • Regulatory Affairs Manager

    5 days ago

    Salt Lake, Utah, United States DSJ Global Full time

    DSJ Global is currently seeking a highly skilled Environmental Compliance Manager to support the growth and success of our industrial composites manufacturing operations in the United States.**Job Summary:**We are looking for an experienced professional to oversee environmental compliance and regulatory affairs for our flagship site in Salt Lake City. The...

  • Pneumococcal Vaccines Global Medical Affairs Lead, non

    1 month ago

    Lake Forest, California, United States Pfizer Full time

    ROLE SUMMARYThis position will assume a senior role within the MDSCA pneumococcal vaccines asset, supervising a team of pneumococcal vaccine medical affairs experts within the Global Respiratory Vaccines Franchise. This team supports medical affairs activities globally, within the global pneumococcal asset for the current (PCV13 and PCV20) and next...

  • Product Safety/Regulatory Affairs Specialist

    1 month ago

    Salt Lake City, United States Hexcel Corporation Full time

    With our strong investment in research and development and our culture of continuous improvement, Hexcel is the industry leader in the manufacturing of advance composite materials, including carbon fiber, woven reinforcements, resins, prepregs, honeycombs and additive manufactured parts. We invite you to join the Hexcel team at various manufacturing sites,...

  • Medical Director, Immunoglobulins, US Medical Affairs, Hospital, MD

    3 weeks ago

    Lake Forest, United States Pfizer Full time

    ROLE SUMMARYThe Medical Director will provide leadership and expertise in Immunoglobulins (IG) contributing to the planning and execution of medical strategies and tactic in the US utilizing clinical understanding of IG patient population. The Medical Director will be an integral member of the US medical affairs and cross-functional US Hospital team(s). The...

  • Medical Director, Immunoglobulins, US Medical Affairs, Hospital, MD

    3 weeks ago

    Lake Forest, California, United States Pfizer Full time

    ROLE SUMMARYThe Medical Director will provide leadership and expertise in Immunoglobulins (IG) contributing to the planning and execution of medical strategies and tactic in the US utilizing clinical understanding of IG patient population. The Medical Director will be an integral member of the US medical affairs and cross-functional US Hospital team(s). The...