Current jobs related to Regulatory Affairs and Labeling Expert - Marquette, Michigan - Resolve Surgical Technologies

  • Marketing Coordinator

    1 week ago

    Marquette, Michigan, United States The Fire Station Full time

    Marketing Assistant Job DescriptionThe Fire Station is seeking a highly motivated and organized Marketing Assistant to support the Chief Marketing Officer and marketing department with a range of marketing activities.Key Responsibilities:Coordinate sponsored vendor placement opportunities, providing vendors with targeted audience exposure through specified...

  • Speech Therapist

    2 weeks ago

    Marquette, Michigan, United States Lifepoint Rehabilitation Full time

    Job SummaryLifepoint Rehabilitation is seeking a highly skilled Speech-Language Pathologist to join our team. As a Speech-Language Pathologist, you will play a vital role in helping patients recover from neurological disorders and injuries by providing expert therapy to maximize speech, language, and swallowing abilities.ResponsibilitiesDevelop and implement...

  • Customer Service Technician I

    4 weeks ago

    Marquette, United States Agiliti Health, Inc. Full time

    Job Description: Who We Are Agiliti is a nationwide company of passionate medical equipment management experts who believe every interaction has the power to change a life. We proudly serve within hospitals, healthcare facilities, and our 90+ local service centers to ensure quality medical equipment is in the right place at the right time for effective...

  • Acute Dialysis Services Program Manager

    4 weeks ago

    Marquette, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program Manager Position requires a licensed RN with some previous experience working in hemodialysis. PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    5 months ago

    Marquette, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program Manager Position requires a licensed RN with some previous experience working in hemodialysis. PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    4 weeks ago

    Marquette, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    5 months ago

    Marquette, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    2 months ago

    MARQUETTE, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    2 weeks ago

    marquette, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    5 months ago

    MARQUETTE, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    5 months ago

    Marquette, Michigan, 49855, Marquette County, MI, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    2 months ago

    Marquette, MI, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program Manager Position requires a licensed RN with some previous experience working in hemodialysis. PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    2 months ago

    Marquette, MI, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    2 months ago

    Marquette, MI, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis. PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

  • Acute Dialysis Services Program Manager

    5 months ago

    Marquette, MI, United States Fresenius Medical Care Full time

    Hospital Dialysis Unit Program ManagerPosition requires a licensed RN with some previous experience working in hemodialysis.PURPOSE AND SCOPE: Ensure the provision of quality patient care to all hospitalized patients in the most efficient manner in accordance with company policy. Provides direct supervision and coordination of inpatient staff. Responsible...

Regulatory Affairs and Labeling Expert

2 months ago

Marquette, Michigan, United States Resolve Surgical Technologies Full time
Position Overview

Resolve Surgical Technologies is a premier Contract Development and Manufacturing Organization (CDMO+) that specializes in innovative product design, development, manufacturing, quality assurance, and regulatory services for leading firms in the medical technology sector.

ROLE SUMMARY:

The Regulatory/Labeling Specialist possesses a foundational knowledge of medical device terminology and global regulations pertaining to medical devices and quality systems. This role is pivotal in supporting regulatory submissions, evaluating product design, manufacturing processes, labeling, quality systems, and material modifications, as well as engaging in change impact assessments. Additionally, the Specialist may be tasked with the planning, development, and execution of labeling documentation and product labeling. This position is essential in ensuring compliance with company policies and procedures while assisting in the maintenance of quality control processes across Resolve Surgical.

KEY RESPONSIBILITIES:

  • Facilitates regulatory submission processes, including US 510(k), EU Technical File/Documentation, and submissions for other global markets.
  • Reviews, supports, and processes regulatory standard operating procedures and work instructions in alignment with relevant regulations, directives, guidance, and standards.
  • Maintains tracking systems for ongoing projects.
  • Manages documentation necessary for product market authorization approvals, licenses, clearances, registrations, and certifications.
  • Assesses product design, labeling, quality systems, manufacturing, and material changes for regulatory implications.
  • Monitors updates to global regulations, directives, standards, and guidance requirements, ensuring timely updates to regulatory documentation and submissions.
  • Provides support during internal audits and inspections by regulatory authorities and certification/accreditation bodies.
  • Develops, edits, reviews, verifies, and processes labeling documentation and medical device labeling in accordance with company procedures and applicable laws/regulations.
  • Ensures that labeling documentation and labels are professional, clear, and compliant with global regulations.
  • Investigates audit findings related to labeling discrepancies.
  • Supports product design, labeling, quality systems, manufacturing, and material changes with respect to labeling impact.
  • This list of duties is not exhaustive and may not encompass all essential functions.

EDUCATION AND EXPERIENCE:

  • A minimum of a Bachelor's degree in a scientific or technical field, ideally in regulatory affairs, engineering, or biological sciences.
  • Alternatively, 2 or more years of relevant experience may be considered in lieu of a degree.

SKILLS AND COMPETENCIES:

  • Technical Skills: Proficient with technology, adept at learning new tools, and utilizing technology to enhance job performance.
  • Innovation: Creative thinker who offers new ideas and embraces change.
  • Job Knowledge: Comprehensive understanding of job responsibilities, with a basic grasp of product development, design controls, and risk management.
  • Organizational Skills: Maintains an efficient workspace and effectively manages time.
  • Project Management: Monitors project statuses and details, ensuring accountability among project owners.
  • Quality Focus: Committed to eliminating errors and improving products/services.

WORK ENVIRONMENT:

  • Office setting with an open layout.
  • Onsite position.
  • No travel required.