Regulatory affairs Jobs in Grand Rapids, MI
Create a job alert for this search
Regulatory affairs • grand rapids mi
Last updated: 1 day ago
UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products.
UFP is an important link in the...Show moreLast updated: 24 days ago
Location : Remote or Allen, TX Duration : 12 months.Interpret, summarize and communicate local, state and federal broadband grant program guiding principles, rules and regulation.Ensure compliance of...Show moreLast updated: 10 days ago
Responsible for internal business projects and programs involving department or cross-functional teams of subject matter experts, delivering products through the design process to completion.Plans ...Show moreLast updated: 8 days ago
Medical Affairs Manager I (Remote).Our client, a world leader in diagnostics and life sciences, is looking for a Medical Affairs Manager I (Remote).
Job Duration : Long term Contract (Possibility Of ...Show moreLast updated: 10 days ago
You can't view this job because it's not available at this time.Show moreLast updated: 30+ days ago
The Battle Creek VA Medical Center is recruiting for a Registered Nurse - Wyoming Specialty Team.The Registered Nurse will function in Ambulatory Care Nursing Service.
Specialty Care Outpatient Staf...Show moreLast updated: 1 day ago
A company is looking for an Associate Human Health Diagnostics Regulatory Affairs professional.Key Responsibilities Prepare, review, and submit regulatory documentation for medical devices Ensur...Show moreLast updated: 30+ days ago
Senior Program Manager Legal Risk and Regulatory Affairs.This role requires close collaboration with cross-functional teams senior leaders and external partners to drive strategic initiatives enhan...Show moreLast updated: 8 days ago
Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members.
We started Oscar in 2012 to create the kind of health insuran...Show moreLast updated: 11 days ago
Associate Director, Medical Affairs.Harrow (Nasdaq : HROW) is a leading North American ophthalmic-focused pharmaceutical company.
Harrow is an incredible entrepreneurial company where we celebrate t...Show moreLast updated: 10 days ago
The format for this internship will be remote, meaning the intern will work virtually.Relocation and housing will not be provided.
Remote work must be completed at a location based in the United Sta...Show moreLast updated: 30+ days ago
Senior Program Manager, Legal, Risk, and Regulatory Affairs.This role requires close collaboration with cross-functional teams, senior leaders, and external partners to drive strategic initiatives,...Show moreLast updated: 10 days ago
Healthcare Regulatory Specialist.We are seeking a strategic and results-driven healthcare regulatory specialist to support new fully insured healthcare product offering.
In this role, you will drive...Show moreLast updated: 9 days ago
Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest ...Show moreLast updated: 10 days ago
Associate Dean, Academic Affairs, Mathematics (BC Online).The purpose of the job is to serve in a management and leadership capacity reporting to the appropriate Dean or Administrator for the respo...Show moreLast updated: 10 days ago
Rush Street Interactive (NYSE : RSI) is a market leader in online casino and sports betting, currently operating real-money gaming with our brands : BetRivers.
We're building bridges between online, s...Show moreLast updated: 7 days ago
Regulatory Program Manager, Identity & Numbering Operations.Join Vonage and help us innovate cloud communications for businesses worldwide!.
The Regulatory Program Manager, Identity & Numbering Oper...Show moreLast updated: 7 days ago
Corporate position that supports Greenville, Big Rapids, and Reed City Hospitals.This hybrid position requires 4+ days per week on site supporting the above hospitals with occasional travel to Gran...Show moreLast updated: 30+ days ago
- Promoted
Quality Assurance and Regulatory Affairs Manager
UFP Technologies, Inc.Grand Rapids, MI, United StatesFull-time
- Promoted
Regulatory Manager - Remote
StaffingGrand Rapids, MI, USRemote
Full-time
- Promoted
Program Manager- Regulatory Oversight
Michigan StaffingGrand Rapids, MI, USFull-time
- Promoted
Medical Affairs Manager I (Remote)
Dawar ConsultingGrand Rapids, MI, USRemote
Temporary
Senior Regulatory & Product Safety Analyst
AmwayAda, MI, United StatesFull-time
Registered Nurse - Wyoming Specialty
Department of Veterans AffairsWyoming, MI, United StatesPermanent
Regulatory Affairs Associate
VirtualVocationsGrand Rapids, Michigan, United StatesFull-time
Senior Program Manager Legal, Risk and Regulatory Affairs
AcrisureGrand Rapids, Michigan, USAFull-time
- Promoted
Senior Analyst, Regulatory
Oscar HealthGrand Rapids, MI, USFull-time
Associate Director, Medical Affairs
HarrowGrand Rapids, MI, USFull-time
Technical Safety & Regulatory Compliance Intern - Summer 2025
StellantisRemote, MIRemote
Full-time +1
Senior Program Manager - Legal, Risk and Regulatory Affairs
ACRISUREGRAND RAPIDS, MI, 100 Ottawa Ave SwFull-time
- Promoted
Healthcare Regulatory Specialist
ProgynyGrand Rapids, MI, USFull-time
Manager, Scientific and Technical Affairs
Thermo FisherGrand Rapids, MI, USFull-time
Associate Dean, Academic Affairs, Mathematics (BC Online)
Broward CollegeGrand Rapids, MI, USFull-time
- Promoted
Government Affairs Director
Rush Street InteractiveGrand Rapids, MI, USFull-time
- Promoted
Regulatory Program Manager, Identity & Numbering Operations
VonageGrand Rapids, MI, USFull-time
RN Clinical Regulatory Compliance Specialist
Spectrum HealthGrand Rapids, Michigan, United States of AmericaFull-time
- machine learning (from $ 177,531 to $ 240,706 year)
- machine learning engineer (from $ 133,750 to $ 240,706 year)
- flooring installer (from $ 39,000 to $ 234,000 year)
- pediatric dentist (from $ 50,000 to $ 225,715 year)
- technical program manager (from $ 132,525 to $ 221,400 year)
- associate dentist (from $ 164,425 to $ 220,750 year)
- general dentist (from $ 50,000 to $ 220,000 year)
- psychiatrist (from $ 72,000 to $ 218,103 year)
- director of software engineering (from $ 175,000 to $ 215,000 year)
- technical director (from $ 54,480 to $ 215,000 year)
- Boston, MA (from $ 125,771 to $ 200,600 year)
- Cambridge, MA (from $ 113,100 to $ 200,200 year)
- Atlanta, GA (from $ 87,750 to $ 195,950 year)
- San Francisco, CA (from $ 103,208 to $ 195,773 year)
- San Jose, CA (from $ 104,003 to $ 194,780 year)
- San Diego, CA (from $ 104,546 to $ 193,259 year)
- New York, NY (from $ 90,142 to $ 189,903 year)
- Seattle, WA (from $ 95,000 to $ 185,000 year)
- Pittsburgh, PA (from $ 49,920 to $ 177,310 year)
- Houston, TX (from $ 69,257 to $ 170,000 year)
The average salary range is between $ 74,006 and $ 170,765 year , with the average salary hovering around $ 105,135 year .
Quality Assurance and Regulatory Affairs Manager
UFP Technologies, Inc.Grand Rapids, MI, United States24 days ago
Job type
- Full-time
Job descriptionDevelops and documents quality plans for new and existing products. Monitors and controls quality systems to ensure effectiveness, efficiency and compliance. Analyzes quality control test results and provides feedback and interpretation to production management or staff. Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality issues. Communicates quality control information to all relevant organizational departments, outside vendors and contractors. Investigates customer returns and complaints. Oversees development and implementation of corrective action measures to prevent re-occurrences. Implements procedures to assure that products comply with customer specifications. Coordinates, as needed, the administration of the defective material identification & disposition program; i.e., the PMDR & MRB program. Monitors & takes corrective / improvement action on key quality measurables; i.e., parts per million (PPM), repeat complaints. Performs or delegates the quality department functions defined in our APQP process. Assures control plans and checking methods and tools therein, are meaningful and effective. Provides training to manufacturing personnel to assist in the preparing definition and monitoring of quality requirements. Monitors existing business practices to ensure compliance with existing policies and procedures (ISO compliance). Serves as the quality management representative, representing the quality management system to external organizations. Supports product development and transfer into production to ensure process capability exists and product requirements are understood. Participates in conducting both internal and vendor audits; including 2 Supports purchasing in supplier performance measurement. Oversees and directs activities of quality department staff in support and maintenance of quality systems. Manages individual performance providing coaching, mentoring and performance feedback to ensure that plant objectives are achieved. Instructs and mentors quality staff in quality control and analytical procedures. Generates and maintains quality operating budgets. Develops and implements quality training programs to train employees to the appropriate and necessary quality systems, techniques and methods including ISO 13485, IATF 16949, and Core Tools. Produces reports regarding nonconformance of products or processes, daily production quality, root cause analyses and quality trends. Manages internal / external calibration of all required measurement devices, gauges and testing equipment. Ensures the QMS includes all Customer Specific Requirements as appropriate. Recommends technical hardware and software as appropriate in support of the annual business plan Annually provides production quantities to the EPA in support of customer FHCS. Ensures all regulatory requests (REACH, RoHS, TSCA, PFAS etc.) from UFP customers are responded to as appropriate. Assists other plants in assuring quality systems are in compliance, as required. Ensures compliance with medical device regulations including local (FDA) and international regulations (ISO 13485, MDSAP, MDR, etc.). Familiar with the preparation and maintenance of regulatory documentation and submissions such as 510(k)s, CE technical files, and product registrations. Acts as the primary liaison with regulatory agencies during inspections, audits, and correspondence. Continuously monitors changes to regulatory requirements and updates internal processes and documentation accordingly. Supports post-market surveillance activities, including adverse event reporting and field action coordination, as required by regulatory authorities. Performs all other duties as assigned or needed. Bachelor's degree or equivalent in quality, operations management or engineering related field. A minimum of 10 years of experience in quality and 5 years of regulatory affairs experience, 5 years of experience in a manufacturing environment, with at least 2 years in a management and / or supervisory capacity. Depending on site location, experience in an ISO environment (ISO 9001 and ISO 13485), . Experience working in regulated environments and knowledge of applicable regulations including 21CFR820, cGMPs, eCFR title 21, compliance with IATF 16949 and the Core Tool. Familiar with regulatory submissions (e.g., 510(k), CE technical files) is strongly preferred. Regulatory Affairs Certification (RAC) or equivalent training is a plus. Certified Quality Engineer (CQE or ASQ) certificate / training a plus. Occasional travel may be required.
About UFP MedTech :
UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company's single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.
UFP Technologies, Inc. offers a competitive benefits package, including but not limited to :
- Medical, Dental, Vision, Life, Disability Insurance
- 401K with a matching contribution
- Paid time off, Paid holidays, Employee discounts and much more!
Location : This position will be on-site full-time in Grand Rapids, MI.
Applicants must be authorized to work for any employer in the U.S. At this time, we are unable to sponsor or assume sponsorship of an employment visa.
Quality Assurance and Regulatory Affairs Manager Summary :
The Quality Assurance & Regulatory Affairs Manager plans, directs and coordinates the development, application, and maintenance of all quality systems for inspecting incoming product, raw material, in-process material and products through finish product. Oversees and directs plans, organizes and develops test plans, prepares test data and subsequent testing of all products. Responsible for managing data during product development and evaluation prior to product release. Responsible for customer, ISO audits and for organizing compliance to regulatory requirements related to manufacturing medical devices. Manages 4-6 Quality Engineers and Quality Technicians. Additionally, this role oversees regulatory affairs activities, ensuring compliance with applicable local and international regulations. The manager is responsible for maintaining regulatory documentation, supporting regulatory submissions, and serving as a liaison with regulatory agencies.
Quality Assurance and Regulatory Affairs Manager Essential Duties and Responsibilities :
nd
and 3
rd
party quality system audits.
Quality Assurance and Regulatory Affairs Manager Qualification Requirements :
UFP Technologies, Inc. is an Equal Opportunity / Affirmative Action employer Minorities / Women / Veterans / Disabled.
#UFP #MEDTECH #MI #IND