Lead Regulatory Affairs Specialist in Clinical Operations

2 weeks ago

Anoka, Minnesota, United States Insulet Corporation Full time


Insulet Corporation, established in 2000, is dedicated to enhancing the lives of our customers through our innovative Omnipod product platform.

Over the past two decades, we have positively impacted the lives of countless patients by leveraging cutting-edge technology that is designed to be wearable, waterproof, and adaptable to various lifestyles.


Position Title:
Senior Clinical Affairs Regulatory Specialist

Department:
Clinical and Medical Affairs

FLSA Status:
Exempt

Position Summary:


This role is pivotal in assessing regulatory obligations and crafting high-quality regulatory documentation pertinent to global clinical research studies, encompassing both pre-market and post-market investigations. The position necessitates collaboration across various departments to ensure that clinical research studies are executed and reported in accordance with relevant global regulations.

Key Responsibilities:

  • Assess and articulate the regulatory landscape for conducting clinical research in targeted regions.
  • Support clinical studies and organizational initiatives by participating in meetings and providing essential clinical regulatory insights and deliverables.
  • Draft high-quality regulatory documents related to clinical study execution, both pre and post-market.
  • Prepare clinical documentation such as safety plans, safety reports, protocol deviation plans, investigator brochures, and other necessary documents as mandated by regulatory authorities and/or study protocols.
  • Review or assist in the creation of clinical documents, including study protocols, clinical study reports, annual and interim reports, ensuring adherence to regulatory compliance.
  • Prepare and submit relevant clinical documentation to global regulatory authorities, Ethics Committees, and Investigational Review Boards, including human research applications, waivers, safety reports, and progress reports.
  • Engage with regulatory authorities to clarify requirements and respond to inquiries for additional information, collaborating cross-functionally to align strategies.
  • Address internal requests for regulatory and clinical research input, as well as clinical documentation to support commercial license/approval submissions, publications, and technical presentations, while collaborating with clinical and other departments regarding global clinical regulatory requirements.
  • Develop additional clinical-related regulatory documents as necessary.
  • Participate in preparation activities to ensure clinical documentation is readily available for internal and external clinical audits/inspections.
Education and Experience:

  • BA or BS degree or equivalent combination of education and experience.

Minimum Qualifications:

  • 7+ years of relevant experience in a medical device, biotechnology, or contract research organization, with direct involvement in regulatory and clinical research, including the drafting of clinical study documentation and regulatory submissions/responses.

  • Proficiency in guidelines, standards, and regulations applicable to medical devices and clinical trials, including 21CFR803, 21CFR812, MDCG /1, ISO 14155, EU MDR 2017, ICH GCP, and country-specific regulatory requirements.
  • RAC Certification is preferred.

Preferred Skills and Competencies:

  • Expertise in MS Word, Excel, and PowerPoint.
  • Demonstrated analytical skills and ability to interpret regulations.
  • Excellent verbal and written communication abilities.
  • Strong initiative, urgency, and commitment to tasks.
  • Exceptional organizational skills with the ability to prioritize and manage multiple tasks effectively.

Travel Requirements:

  • This position may require occasional travel, up to 10% of the time (domestic and international).

Note:

This position offers the flexibility of 100% remote working arrangements, allowing for virtual work from home or a hybrid on-site/virtual model as preferred.


Additional Information:


The US base salary range for this full-time position is $98,000 to $148,000. Salary ranges are determined by role, level, and location.

The displayed range reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US.

Individual pay within the range is influenced by work location and additional factors, including job-related skills, experience, and relevant education or training.

Compensation details listed in US role postings reflect base salary only and do not include bonuses, equity, or benefits.


At Insulet Corporation, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)

  • Senior Regulatory Affairs Specialist in Clinical Operations

    2 weeks ago

    Anoka, Minnesota, United States Insulet Corporation Full time

    Insulet Corporation, founded in 2000, is dedicated to enhancing the lives of our customers through our innovative Omnipod product platform. Over the past two decades, we have positively impacted the lives of countless patients by leveraging cutting-edge technology that is both wearable and adaptable to various lifestyles.Position Title: Senior Clinical...

  • Electrical Solutions Specialist Lead

    7 days ago

    Anoka, Minnesota, United States nVent Full time

    Electrical Solutions SpecialistWe're seeking a talented individual to join our team as an Electrical Solutions Specialist. As a key member of our organization, you will play a crucial role in advancing our success and your own career.At nVent, we connect and protect our customers with inventive electrical solutions. Our comprehensive portfolio of enclosures,...

  • Manufacturing Operations Specialist

    2 days ago

    Anoka, Minnesota, United States nVent Full time

    About the RoleWe are seeking a highly skilled Manufacturing Operations Specialist to join our team at nVent. As a key member of our Enclosures Segment, you will play a critical role in providing exceptional customer support for our rapidly growing Data Center business.Key ResponsibilitiesCustomer Support: Ensure all customer requests are responded to in a...

  • Staff Physician Position at the Northwest Metro Outpatient Clinic

    4 days ago

    Anoka, Minnesota, United States Department Of Veterans Affairs Full time

    About the PositionWe are seeking a highly skilled and compassionate Staff Physician to join our team at the Northwest Metro Outpatient Clinic. As a Staff Physician, you will be responsible for providing high-quality patient care, working collaboratively with our multidisciplinary team, and contributing to the development of our clinical programs.Key...

  • Quality Assurance Engineer for Suppliers

    2 weeks ago

    Anoka, Minnesota, United States Jobot Full time

    Supplier Quality Assurance for Medical Devices: Design Control EnhancementThis position is hosted by Jobot.Compensation: $95,000 - $115,000 annuallyAbout Us:Join a reputable and expanding Medical Device Manufacturer. We are committed to innovation and excellence in our field.Benefits of Joining Our Team:Opportunities for professional growthCollaborative work...

  • Lead Geotechnical Specialist

    5 days ago

    Anoka, Minnesota, United States Geosyntec Consultants Full time

    About the RoleWe are seeking a highly experienced and skilled Principal Geotechnical Engineer to join our team at Geosyntec Consultants. As a key member of our geoenvironmental and geotechnical practice, you will play a critical role in supporting our operations in the Boston area from our Acton, MA office, with a hybrid or remote work schedule available.Key...

  • Production Operations Manager

    7 days ago

    Anoka, Minnesota, United States nVent Full time

    Electrical Solutions SpecialistWe're seeking a talented individual to fill a key role in our organization as an Electrical Solutions Specialist. As a crucial member of our team, you will play a vital part in driving our success and advancing your own career.nVent is a leading provider of innovative electrical solutions, connecting and protecting our...

  • Lead Environmental Engineer

    2 weeks ago

    Anoka, Minnesota, United States Geosyntec Consultants Full time

    Position Overview:Are you ready to embark on a meaningful career that contributes to environmental sustainability? Geosyntec Consultants is seeking a Senior Staff Engineer specializing in Dredging, Excavation, and Capping to enhance our sediment and waterfront remediation division. The ideal candidate will possess a strong engineering background and be...

  • Design Engineer, Sustaining Specialist

    2 days ago

    Anoka, Minnesota, United States nVent Full time

    About the RoleWe're seeking a highly skilled Design Engineer, Sustaining Specialist to join our team at nVent. As a key member of our organization, you will play a critical role in advancing our success and driving innovation in the field of electrical solutions.Key ResponsibilitiesCollaborate with cross-functional teams to improve product efficiency,...

  • Quality Assurance Specialist

    2 days ago

    Anoka, Minnesota, United States nVent Full time

    Job SummarynVent is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality assurance support and leading root cause problem-solving activities to improve internal and external quality levels.Key ResponsibilitiesLead problem-solving activities for product and...

  • Machine Operator

    7 days ago

    Anoka, Minnesota, United States Aerotek Full time

    Job SummaryWe are seeking a skilled Machine Operator to join our team at Aerotek. As a key member of our production team, you will be responsible for operating machinery and assembling plastic parts for Aerospace applications.Key ResponsibilitiesOperate machinery to assemble plastic partsWork off work orders to ensure efficient productionDocument all...

  • Client Success Specialist

    2 weeks ago

    Anoka, Minnesota, United States Marvin Full time

    Client Success SpecialistID DepartmentCustomer SupportPosition TypeRegularJob OverviewThe Client Success Specialist plays a vital role in bringing our mission to fruition by supporting the Client Success team in navigating customers through their experience with Marvin Replacement. This team is dedicated to crafting an outstanding, tailored journey by...

  • Cleaning Specialist

    2 days ago

    Anoka, Minnesota, United States Cloud Contents Full time

    Job OverviewCloud Contents is a leading provider of personal property restoration services. We specialize in helping customers and clients recover from damage caused by fire, water, and mold. We are seeking a skilled Cleaning Specialist to join our team and play a key role in the restoration process.Key Responsibilities:Meet with customers and clients on job...

  • Procurement Specialist

    2 days ago

    Anoka, Minnesota, United States 24Restore Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Procurement Specialist to join our team at 24Restore. As a key member of our operations team, you will be responsible for managing the procurement process, ensuring timely delivery of materials, and maintaining strong relationships with suppliers.Key ResponsibilitiesMaterial...

  • Executive Director of Operations

    5 days ago

    Anoka, Minnesota, United States Domino's Pizza LLC Full time

    Job SummaryWe are seeking a highly skilled and experienced Executive Director of Operations to join our team at Domino's Pizza LLC. As a key member of our management team, you will be responsible for overseeing the day-to-day operations of our restaurants, ensuring that our high standards of quality, service, and customer satisfaction are consistently...

  • Lead Senior Engineer in Environmental Remediation

    2 weeks ago

    Anoka, Minnesota, United States Geosyntec Consultants Full time

    Position Overview:Are you ready to advance your career while making a significant impact on environmental sustainability? Geosyntec Consultants is seeking a Senior Staff Engineer specializing in Dredging, Excavation, and Capping to enhance our sediment and waterfront remediation team. The ideal candidate will possess a strong foundation in engineering...

  • Senior Accounting Specialist

    2 weeks ago

    Anoka, Minnesota, United States THE PAPER STORE Full time

    Job OverviewThe Paper Store is dedicated to being the leading destination for all of our customer's gift-giving needs. Our mission is to share our enthusiasm for The Paper Store with every customer, during each visit, by exceeding their expectations for both selection and service.The Senior Accounting Specialist is accountable for the comprehensive...

  • Engineering Operations Specialist

    4 days ago

    Anoka, Minnesota, United States Insulet Corporation Full time

    Job SummaryInsulet Corporation is seeking a highly motivated and experienced Manufacturing Engineer to join our team. As a key member of our manufacturing operations team, you will be responsible for driving process improvements and ensuring the highest level of quality in our manufacturing processes.Key ResponsibilitiesMaintain a cGMP compliant environment...

  • MIG Welder

    2 days ago

    Anoka, Minnesota, United States Aerotek Full time

    **Job Title: MIG Welder - Production Specialist****Job Description**We are seeking a skilled MIG Welder to join our production team at Aerotek. As a MIG Welder - Production Specialist, you will work in a fast-paced manufacturing environment, performing Pulse (MIG) welding on mild steel using weld fixtures and weld symbols to complete units within a set...

  • Accounts Payable Specialist

    6 days ago

    Anoka, Minnesota, United States THE PAPER STORE Full time

    The Paper Store - Accounts Payable SpecialistThe Paper Store stands out as a premier source for distinctive gifts and unparalleled customer service. Our mission is to surpass customer expectations by offering a diverse range of high-quality products along with exceptional service. We are seeking an Accounts Payable Specialist to contribute to our Corporate...