Associate II, Regulatory Affairs

5 days ago

San Clemente, United States ICU Medical, Inc. Full time
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.

This is a hybrid role based in Southington, CT

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

• A minimum of two years of experience in Medical Products Industry 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.

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 Associate

    1 month ago

    San Mateo, United States Collabera Full time

    Description Home Search Jobs Job Description Regulatory Affairs Associate - II Contract: Foster City, California, US Salary: $60.00 Per Hour Job Code: 352568 End Date: 2024-09-08 Days Left: 28 days, 3 hours left Apply Pay range: $55 to $50/hr.Responsibilities: Collaborate with the RA CMC team to meet deliverables and timelines Ensure data...

  • Executive Director, Regulatory Affairs

    6 days ago

    San Diego, United States Regulatory Affairs Professionals Society Full time

    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

  • Executive Director, Regulatory Affairs

    5 days ago

    San Diego, United States Regulatory Affairs Professionals Society Full time

    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

  • Regulatory Affairs Associate

    3 months ago

    San Mateo, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...

  • Regulatory Affairs CMC Associate

    3 months ago

    San Mateo, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

  • Regulatory Affairs CMC Associate

    3 months ago

    San Mateo, United States The Fountain Group Full time

    Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational...

  • Regulatory Affairs Specialist

    6 days ago

    San Francisco, California, United States Pharmatech Associates Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmatech Associates. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our clients' projects with global regulatory requirements.Key ResponsibilitiesCMC and Clinical Regulatory Expertise: You will...

  • Senior Manager or Associate Director, Regulatory Affairs

    1 month ago

    San Diego, United States Contineum Therapeutics Full time

    Position Summary:   Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated...

  • Senior Manager or Associate Director, Regulatory Affairs

    4 weeks ago

    San Diego, United States Contineum Therapeutics Full time

    Position Summary:Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory...

  • Senior Manager or Associate Director, Regulatory Affairs

    4 weeks ago

    San Diego, United States Contineum Therapeutics Full time

    Position Summary:Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory...

  • Senior Manager or Associate Director, Regulatory Affairs

    1 month ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Summary:Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory...

  • Regulatory Affairs Manager

    2 months ago

    San Antonio, United States KYDA Partners Ltd Full time

    The KYDA Partners team is seeking a Regulatory Affairs Manager to lead and manage the regulatory affairs department, ensuring compliance with regulatory standards and the quality management system.Key Responsibilities:Internal Audits:Review and approve audit agendas, plans, and summary reports.External Audits:Facilitate and participate in external...

  • Regulatory Affairs Manager

    1 week ago

    san antonio, United States KYDA Partners Ltd Full time

    The KYDA Partners team is seeking a Regulatory Affairs Manager to lead and manage the regulatory affairs department, ensuring compliance with regulatory standards and the quality management system.Key Responsibilities:Internal Audits:Review and approve audit agendas, plans, and summary reports.External Audits:Facilitate and participate in external...

  • Regulatory Affairs Manager

    2 months ago

    San Antonio, United States KYDA Partners Ltd Full time

    The KYDA Partners team is seeking a Regulatory Affairs Manager to lead and manage the regulatory affairs department, ensuring compliance with regulatory standards and the quality management system.Key Responsibilities:Internal Audits:Review and approve audit agendas, plans, and summary reports.External Audits:Facilitate and participate in external...

  • Regulatory Affairs Director

    7 days ago

    San Diego, California, United States Modular Medical Inc Full time

    Job Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...

  • Regulatory Affairs Manager

    2 months ago

    San Diego, California, United States Surf Search Full time

    Join Our Team as a Regulatory Affairs ManagerWe are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within...

  • Regulatory Affairs Leader

    1 week ago

    San Diego, California, United States Radionetics Oncology Full time

    About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

  • Manager, Regulatory Affairs

    2 weeks ago

    San Jose, United States Outset Medical Full time

    Company Overview Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology...

  • Regulatory Affairs Specialist

    4 days ago

    San Francisco, California, United States San Francisco Health Plan Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at San Francisco Health Plan. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring our organization's compliance with state and federal regulations.Key ResponsibilitiesSubmit regulatory reports, including the...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...