Medical Affairs Operations Manager

1 month ago

Minneapolis, Minnesota, United States Coloplast AS Full time


This position is member of the clinical science & office of medical affairs team. This role is responsible for driving and managing medical affairs activities and logistics, assuring high quality and compliant processes and procedures. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.



Major Areas of Accountability

  • Develop standard processes and procedures for medical affairs activities, including, but not limited to, dissemination of information, participation in complaint handling process and review, responding to scientific inquiries
  • Development and implementation of a process for responding to field inquiries, customer inquiries and other relevant medical affairs related inquiries
  • Establish and maintain standard operating procedures, policies, and work instructions for the medical affairs department, ensuring they are in compliance with external standards and oversight bodies
  • Oversee development and updates to instructions for use master text, management of translations of medical affairs documents as required
  • Establish calendar and project tracking for annual reports and updates of relevant clinical documents for relevant products
  • Develop and maintain project trackers and metrics as requested
  • Support activities to further medical affairs initiatives, education and collaboration across cross-functional partners
  • Work in close partnership within US medical affairs team and other cross-functional team partners to strategically develop and manage US publication plan and conference plan.
  • Work in close collaboration to plan, coordinate and execute all logistics related to congress planning
  • Support material development and logistics for internal review process for all externally used field medical materials as well as internal training materials.
  • Development and execution of communication tools for medical affairs activities
  • Provide medical affairs support on project teams as applicable
  • Participate in benefit/risk ratio assessment for vigilance and Risk Management Files
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
  • Other duties as assigned


Basic Qualifications

  • 5+ years' experience within clinical research and/or medical affairs activities, preferably with medical devices
  • Bachelor's degree (health science or biotech area). Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD)
  • Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
  • Ability to travel – 10-25%

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world ́s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on .

Watch the film. Follow us on LinkedIn. Like us on Facebook.

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

57295

#LI-CO #LI-HYBRID

  • Medical Affairs Operations Manager

    4 weeks ago

    Minneapolis, Minnesota, United States Coloplast Full time

    Medical Affairs Operations ManagerLocation:Minneapolis, MN, US Job Family: Research & DevelopmentCountry/Region: United StatesThis position is member of the clinical science & office of medical affairs team. This role is responsible for driving and managing medical affairs activities and logistics, assuring high quality and compliant processes and...

  • Senior Manager, Medical Affairs

    2 months ago

    Minneapolis, Minnesota, United States Coloplast Full time

    Senior Manager, Medical AffairsLocation:Minneapolis, MN, US Job Family: Research & DevelopmentCountry/Region: United StatesThis position is member of the clinical science & office of medical affairs team. is the role is responsible for managing the medical affairs teams for Men's Health and Women's Health, as well as driving and managing clinical...

  • Manager of Student Affairs

    2 months ago

    Minneapolis, Minnesota, United States University of Minnesota Full time

    Join Our TeamManager of Student Affairs OpportunityAre you passionate about student success and looking to make a positive impact in the field of student affairs? We are seeking a dedicated and experienced Manager of Student Affairs to lead and coordinate operations for the Student Affairs Office in the Doctor of Medicine (MD) program. In this role, you will...

  • Medical Affairs Program Manager

    3 weeks ago

    Minneapolis, Minnesota, United States Coloplast AS Full time

    This position is a member of the Clinical Science & Office of Medical Affairs team. This role is responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and providing clinical expertise as required. This position will comply with regulations and ensure...

  • Medical Affairs Program Manager

    4 weeks ago

    Minneapolis, Minnesota, United States Coloplast Full time

    Medical Affairs Program ManagerLocation:Minneapolis, MN, US Job Family: MarketingCountry/Region: United StatesThe Medical Affairs Program Manager is responsible for supporting evidence strategies and for executing Coloplast agenda in the clinical community. The Chronic Care business at Coloplast has products to help patients with intimate healthcare needs....

  • Medical Affairs Program Manager

    1 month ago

    Minneapolis, Minnesota, United States Coloplast AS Full time

    The Medical Affairs Program Manager is responsible for supporting evidence strategies and for executing Coloplast agenda in the clinical community. The Chronic Care business at Coloplast has products to help patients with intimate healthcare needs. The patient population spans spinal cord injury, cancer, Multiple Sclerosis, spina bifida, and many more. The...

  • Global Regulatory Affairs Expert

    6 days ago

    Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    Company OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems is at the forefront of the medical industry, focused on improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who have not found consistent relief through CPAP therapy. We are...

  • Lead Regulatory Affairs Expert

    2 weeks ago

    Minneapolis, Minnesota, United States Laborie Medical Technologies Corp Full time

    At Laborie Medical Technologies, we are dedicated to enhancing healthcare and preserving human dignity. Our commitment to making a positive difference in the lives of patients worldwide drives our mission. We foster an environment that promotes professional growth and a sense of belonging, empowering our employees to achieve their career aspirations while...

  • Lead Regulatory Affairs Expert

    1 week ago

    Minneapolis, Minnesota, United States Laborie Medical Technologies Corp Full time

    At Laborie Medical Technologies, we are committed to enhancing healthcare and preserving human dignity. Our mission drives us to make a significant difference in the lives of patients worldwide. We foster an environment that promotes professional growth and a sense of belonging, empowering our employees to contribute meaningfully to our goals. Our culture...

  • Global Regulatory Affairs Expert

    5 days ago

    Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    Company OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems is at the forefront of medical innovation, focusing on improving the lives of individuals dealing with Obstructive Sleep Apnea (OSA). Our cutting-edge FDA-approved device is designed to reduce the severity of OSA for those who find limited success with traditional CPAP therapy. We are dedicated...

  • Global Regulatory Affairs Expert

    1 week ago

    Minneapolis, Minnesota, United States Inspire Medical Systems I Full time

    Company OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems stands at the forefront of the medical industry, committed to improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who find limited success with traditional CPAP therapy. We...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Minneapolis, Minnesota, United States Mlnneapolis heart institute foundation Full time

    The Minneapolis Heart Institute Foundation (MHIF) is on the lookout for a dedicated Quality & Regulatory Affairs Specialist II to help advance MHIF's mission of eradicating heart and vascular diseases. Our commitment is to enhance cardiovascular health through pioneering research and educational initiatives. With over four decades of experience, MHIF stands...

  • Regulatory Affairs Associate II

    2 weeks ago

    Minneapolis, Minnesota, United States Boston Scientific Gruppe Full time

    About Us:At Boston Scientific Gruppe, we are dedicated to enhancing lives through innovative medical solutions. Our advanced products and technologies play a crucial role in diagnosing and treating a variety of medical conditions. We are committed to continuous innovation in key sectors and expanding our reach into emerging markets.In the field of Rhythm...

  • Regulatory Affairs Specialist

    14 hours ago

    Minneapolis, Minnesota, United States The Judge Group Full time

    Job SummaryThe Judge Group is seeking a highly skilled Regulatory Affairs Specialist to join our team on a 12-month contract basis. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory matters.Key ResponsibilitiesSupport daily Regulatory Affairs...

  • Regulatory Affairs Associate II

    2 weeks ago

    Minneapolis, Minnesota, United States Boston Scientific Gruppe Full time

    About Boston Scientific Gruppe:At Boston Scientific, we are dedicated to enhancing lives through innovative medical solutions. Our advanced products and technologies play a crucial role in diagnosing and treating a variety of medical conditions. We are committed to continuous innovation in key areas and expanding our reach into new markets.In the Rhythm...

  • Advanced Regulatory Affairs Officer

    2 weeks ago

    Minneapolis, Minnesota, United States Integer Holdings Corporation Full time

    Company Overview: Integer Holdings Corporation is a leading global provider of medical device outsourcing solutions, dedicated to enhancing patient care through innovative technologies. Our commitment to quality and excellence drives our success in the cardiac, neuromodulation, orthopedics, vascular, advanced surgical, and portable medical markets.Core...

  • Senior Regulatory Affairs Consultant

    2 weeks ago

    Minneapolis, Minnesota, United States Integer Holdings Corporation Full time

    Company Overview: Integer Holdings Corporation is a leading provider of medical device outsourcing solutions, specializing in the cardiac, neuromodulation, orthopedics, vascular, advanced surgical, and portable medical markets. Our commitment to innovation and quality enhances the lives of patients globally.Core Values: At Integer, we uphold a set of core...

  • Public Affairs Consultant Senior

    1 month ago

    Minneapolis, Minnesota, United States Allina Health Full time

    Number of Job Openings Available:1Date Posted:July 16, 2024Department: Public PolicyShift:Day (United States of America)Shift Length:8 hour shiftHours Per Week:40Union Contract:Non-UnionWeekend Rotation: NoneJob Summary:Allina Health is engaging in multiple, significant, transformative strategic initiatives in 2024 and beyond that require a role dedicated to...

  • Senior Manager, Professional Affairs

    3 days ago

    Minneapolis, Minnesota, United States Bausch + Lomb Full time

    About the RoleBausch + Lomb, a leading global eye health company, is seeking a highly skilled Senior Manager, Professional Affairs to join our team. As a key member of our Professional Strategy function, you will play a critical role in cultivating strong relationships with Key Opinion Leaders (KOLs), key accounts, educational institutions, and professional...

  • Student Affairs Graduate Assistant

    3 days ago

    Minneapolis, Minnesota, United States Dunwoody College Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Graduate Assistant to support our retention initiatives at Dunwoody College. The successful candidate will work closely with our Student Affairs team to design and implement programs and services that enhance the student experience and contribute to the retention efforts of the College.Key...