Current jobs related to Senior Regulatory Affairs Specialist in Clinical Operations - Anoka, Minnesota - Insulet Corporation
-
Northwest Metro Outpatient Clinic Physician
1 month ago
Anoka, Minnesota, United States Department Of Veterans Affairs Full timeAbout the JobWe are seeking a highly skilled and compassionate Family Medicine or Internal Medicine trained primary care physician to join our team at the Northwest Metro Community Based Outpatient Clinic. As a member of our team, you will have the opportunity to provide high-quality patient care and make a meaningful difference in the lives of our...
-
Warehouse Operations Specialist
1 week ago
Anoka, Minnesota, United States Aerotek Full timeJob SummaryAerotek is seeking a skilled Warehouse Operations Specialist to join our team. As a key member of our logistics team, you will be responsible for the efficient receipt, storage, and shipment of water softeners at our Anoka, MN facility.Key Responsibilities:Ensure accurate and timely receipt and storage of inventoryCoordinate with shipping and...
-
Learning and Development Specialist
2 weeks ago
Anoka, Minnesota, United States Innova Solutions Full timeJob Title: Learning and Development SpecialistInnova Solutions is seeking a highly skilled Learning and Development Specialist to join our team. As a Learning and Development Specialist, you will be responsible for designing, developing, and implementing training programs that meet regulatory requirements and business needs.Key Responsibilities:Implement...
-
Care Transition Specialist
2 days ago
Anoka, Minnesota, United States Knute Nelson Full timeJob SummaryWe are seeking a skilled Care Transition Specialist to join our team at Knute Nelson. As a key member of our sales team, you will play a critical role in ensuring seamless care transitions for our patients and families.Key ResponsibilitiesCollaborate with Facilities: Work closely with key contacts within assigned facilities to ensure understanding...
-
Learning and Development Specialist
2 weeks ago
Anoka, Minnesota, United States Innova Solutions Full timeJob Title: Learning and Development SpecialistInnova Solutions is seeking a highly skilled Learning and Development Specialist to join our team. As a Learning and Development Specialist, you will be responsible for designing, developing, and delivering training programs that meet the needs of our clients.Key Responsibilities:Develop and implement training...
-
Learning and Development Specialist
4 weeks ago
Anoka, Minnesota, United States Innova Solutions Full timeJob Title: Learning and Development SpecialistInnova Solutions is seeking a highly skilled Learning and Development Specialist to join our team. As a Learning and Development Specialist, you will be responsible for designing, developing, and delivering training programs that meet the needs of our clients.Key Responsibilities:Design and develop training...
-
Warehouse Operations Specialist
4 weeks ago
Anoka, Minnesota, United States DECOPAC INC. Full timeJob SummaryWe are seeking a highly motivated and detail-oriented individual to join our team as a Warehouse Pick Pack Specialist. In this role, you will be responsible for accurately picking and packing customer orders in our distribution center.Key ResponsibilitiesPick, pack, and check orders to ensure quality and timely processing.Operate integrated...
-
Weekend Culinary Specialist
1 week ago
Anoka, Minnesota, United States Suite Living Senior Care Full timeJob OpportunityAt Suite Living Senior Care, we are seeking a reliable and detail-oriented Weekend Cook to join our team.The ideal candidate will have a passion for the well-being of our elderly community and be adaptable to frequent shifts in direction.Responsibilities include cooking and clean-up, with menus planned in advance.Requirements include a high...
-
Extrusion Machine Operator
1 week ago
Anoka, Minnesota, United States Aerotek Full time**Job Title: Extrusion Machine Operator - Manufacturing Specialist****About Us:** Aerotek is a leading manufacturer in the automotive and marine industries, dedicated to delivering high-quality fabrics and materials. We pride ourselves on fostering a collaborative and safe work environment.**Job Description:** We are seeking a reliable and detail-oriented...
-
Senior Mechanical Engineer Position
1 week ago
Anoka, Minnesota, United States Phantom Staffing Full timeAbout the JobWe are seeking a highly skilled Senior Mechanical Engineer to lead the design and development of advanced electro-mechanical laboratory soil testing equipment.Key Responsibilities:Develop and integrate electro-mechanical systems for laboratory soil testing, ensuring seamless operation of mechanical and electrical components.Create comprehensive...
-
Senior Mechanical Engineer Position
2 weeks ago
Anoka, Minnesota, United States Phantom Staffing Full timeAbout the RoleWe are seeking a highly skilled Senior Mechanical Engineer to lead the design and development of advanced electro-mechanical laboratory soil testing equipment. This role involves overseeing the end-to-end process from initial concept through to production, ensuring our products meet industry standards.Key ResponsibilitiesDevelop and integrate...
-
Ecommerce Operations Specialist
2 days ago
Anoka, Minnesota, United States THE PAPER STORE Full timeJob DescriptionThe Paper Store is seeking a highly skilled Ecommerce Specialist to join our team. As an Ecommerce Specialist, you will be responsible for executing promotional campaigns, troubleshooting customer service challenges, and enhancing the daily customer shopping experience.Key Responsibilities:Product Setup/Content/MerchandisingManage internal and...
-
Senior Quality Assurance Engineer
4 weeks ago
Anoka, Minnesota, United States MultiSource Mfg Full timeJob SummaryWe are seeking a highly skilled Senior Quality Engineer to join our team at MultiSource Manufacturing. As a key member of our quality team, you will be responsible for ensuring the highest level of quality in our products and processes.Key ResponsibilitiesCreate and implement quality procedures, control plans, and other quality tools to ensure...
-
Anoka, Minnesota, United States Minnesota Careers Full timeJob SummaryWe are seeking a highly skilled Senior Clinical Psychologist to join our team at the Anoka Metro Regional Treatment Center. As a Senior Clinical Psychologist, you will be responsible for providing individual and group psychotherapy, psychological screening and assessment services, and consultation to program delivery staff and other professionals....
-
Senior Care Development Specialist
1 day ago
Anoka, Minnesota, United States Comfort Keepers Anoka and White Bear Lake Full timeOverview:Comfort Keepers of Anoka and White Bear Lake is seeking a highly skilled and empathetic Client Care Coordinator to play a vital role in ensuring our clients receive exceptional care while expanding our reach within the community. This dynamic position requires a self-driven individual with a passion for senior care, skilled in relationship building,...
-
Senior Manufacturing Engineer
2 weeks ago
Anoka, Minnesota, United States Insulet Corporation Full timeJob Title: Senior Manufacturing EngineerInsulet Corporation is seeking a highly motivated and experienced Senior Manufacturing Engineer to join our team. As a key member of our Global Manufacturing Engineering Group, you will play a critical role in driving product and process improvements to support our Operations (3) main objectives: Best Quality, Highest...
-
Care Transition Specialist
7 days ago
Anoka, Minnesota, United States Knute Nelson Full timeCare Transition SpecialistThis role is responsible for delivering exceptional customer service and support within assigned facilities to ensure a high level of satisfaction and timely transitions of care. The Care Transition Specialist will collaborate closely with key contacts within strategically assigned facilities to ensure understanding of services and...
-
Mental Health Therapist/Clinical Specialist
2 weeks ago
Anoka, Minnesota, United States Volunteers of America Full timeAbout the RoleWe are seeking a highly skilled Mental Health Therapist to join our team at Volunteers of America. As a key member of our clinical team, you will play a vital role in providing intensive, therapeutic, and residential care to adolescents who are experiencing mental health and/or substance use issues.Key ResponsibilitiesDevelop and implement...
-
Warehouse Operations Manager
4 weeks ago
Anoka, Minnesota, United States Virtex dba Altron LLC Full timeJob SummaryThe Warehouse Supervisor is responsible for overseeing daily warehouse operations, managing staff, and ensuring inventory accuracy. This role involves coordinating activities related to the receipt, storage, and distribution of goods.Key ResponsibilitiesLead and motivate warehouse team members to achieve productivity and performance goals.Schedule...
-
Automotive Operations Specialist
2 weeks ago
Anoka, Minnesota, United States Carvana Full timeAbout UsADESA, a Carvana-owned company, operates over 50 locations across the US. Our auto auctions, spanning up to 200 acres, offer a wide range of vehicle services, including repair and reconditioning, auction remarketing, and distribution center operations. Our inventory comprises hundreds of thousands of vehicles across North America, from retail to...
Senior Regulatory Affairs Specialist in Clinical Operations
2 months ago
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 Affairs Regulatory Specialist
Department:
Clinical and Medical Affairs
FLSA Status:
Exempt
Position Summary:
This role is pivotal in assessing regulatory obligations and crafting high-caliber regulatory documentation related to global clinical research initiatives, encompassing both pre-market and post-market studies. The position requires collaboration across various departments to ensure that clinical research activities are executed and reported in accordance with relevant global regulations.
- Assess and articulate the regulatory environment for conducting clinical research in targeted regions.
- Contribute to clinical studies and business projects by participating in meetings and providing essential clinical regulatory insights and deliverables.
- Draft high-quality regulatory documents pertinent to clinical study execution, both pre and post-market.
- Generate clinical documentation such as safety plans, safety reports, protocol deviation plans, investigator brochures, and other required documents for regulatory bodies and 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 standards.
- 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 requests for additional information, working collaboratively to align strategies.
- Address internal inquiries for regulatory and clinical research input, and clinical documentation to support commercial licensing/approval submissions, publications, and technical presentations, while collaborating with clinical and other departments regarding global clinical regulatory standards (EU MDR, MEDDEV 2.7/1, MDCG).
- Develop additional clinical-related regulatory documents as necessary.
- Participate in preparation activities to ensure clinical documentation is readily accessible for internal and external clinical audits/inspections.
- BA or BS degree or an equivalent combination of education and experience.
Minimum Qualifications:
- 7+ years of relevant experience in the medical device, biotechnology, or contract research sectors, with direct involvement in regulatory and clinical research, including the drafting of clinical study documentation and regulatory submissions/responses.
- Proficiency in applicable guidelines, standards, and regulations for 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.
- Strong analytical skills and the ability to interpret regulations.
- Exceptional verbal and written communication skills.
- Proactive approach, urgency, and commitment to tasks.
- Excellent 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 is eligible for remote working arrangements, allowing for full-time virtual work or a hybrid on-site/virtual setup 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.
Your Talent Acquisition Specialist can provide more details about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the 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.
