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NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.

Compensation Target:

$150,000.00

Job Description:

•\tLead the development and execution of global regulatory strategies for medical devices, in vitro diagnostics, combination products, and related technologies across all stages of product development.
•\tServe as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives.
•\tPrepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies, including FDA, Health Canada, and other global regulators.
•\tDevelop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages.
•\tLead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions.
•\tAct as a trusted advisor to clients by interpreting regulatory requirements, assessing regulatory impact, and recommending practical, risk-based pathways to market.
•\tManage multiple client engagements simultaneously, ensuring high-quality deliverables, adherence to timelines and budgets, and proactive communication of project risks and issues.
•\tSupport business development activities by engaging with prospective clients, defining project scope, contributing to proposals, estimating effort, and identifying opportunities for additional NAMSA services.
•\tMentor and coach consultants and other associates, providing technical leadership and contributing to the professional development of colleagues.
•\tContribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and other scientific or marketing initiatives.
•\tDrive continuous improvement of consulting processes, service delivery, and regulatory best practices across the organization.
•\tMaintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends to ensure clients receive current and effective regulatory advice.

Qualifications & Technical Competencies:

7+ years of medical device regulatory experience, including strategic leadership of product development programs.
Advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred.
Prior FDA, regulatory authority, or medical device industry experience required.
Expertise in one or more areas, including regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs.
Strong knowledge of global medical device regulations, standards, and quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.).
Demonstrated ability to develop regulatory strategies, assess regulatory impact, and support interactions with global regulatory agencies.
Strong analytical, problem-solving, communication, writing, and presentation skills.
Ability to lead cross-functional teams, manage multiple priorities, and deliver high-quality results within timelines and budgets.
Commitment to continuous learning and professional development in emerging regulatory and industry topics.

Working Conditions:

The physical demands described here must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands to finger, handle, or feel, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and the ability to adjust focus.
Extensive use of a computer keyboard.
Travel approximately 5 to 10% of the time.

The compensation grade range for this position is:

$101,600.00 - $197,500.00

Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

","job_type",[73],"location_cities",[],"location_city_states",[],"location_geos",[],"location_regions",[],"pay_period","annual","pay_structure","salary","posted_datetime",1790812800,"priority",2,"remote_type","Location-based","salary_from",101600,"salary_to",197500,"searchable",true,"skills",[],"supplemental_pay",[],"tags",[],"talent_network","title","Senior Regulatory Consultant","Full-time","_geo",[97,98],"city","Minneapolis","2027794",[],"

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.

Compensation Target:

$24.00

Job Description:

For new graduates interested in building a career in animal care, veterinary science, or preclinical research, these roles offer opportunities to turn classroom knowledge and hands-on experience into meaningful work. From daily animal care and research support to surgical preparation, anesthesia monitoring, recovery, and pathology, each position provides exposure to a different area of laboratory animal science and the research process. Depending on your education, experience, and interests, these opportunities can help you strengthen your technical skills while exploring where you’d like to grow your career.

Qualifications & Technical Competencies:

Animal Care Technician - Large & Small Animal
Provides daily animal husbandry and welfare support, including feeding, cleaning and sanitation, health observations, enrichment, animal handling and movement, preventive care, and documentation. May also assist with procedures and administer minor treatments under veterinary direction. Requires a high school diploma or GED; prior animal handling experience and ALAT certification are preferred.

Starting Pay Range: 20-22/hr

Surgical Technician Assistant

Supports surgical and cath lab procedures through room setup, instrument sterilization, equipment maintenance, and supply organization. High school diploma required; animal-related experience or education is preferred.

Starting Pay Range: $19-21/hr

Research Technician – Large & Small Animal

Provides research and veterinary support for small animals, including test-agent dosing, health monitoring, blood collection, occasional surgical and anesthesia support, post-operative care, medication administration, and animal husbandry. Requires a scientific bachelor’s degree or veterinary technology associate degree.

Starting Pay Range: 22-24/hr

Surgical Technician

Supports surgical and interventional procedures by monitoring anesthesia and vitals, administering medications, collecting samples, assisting with imaging equipment, and maintaining surgical instruments and equipment. Requires a scientific bachelor’s degree or veterinary technology associate degree; 0–2 years of related experience.

Starting Pay Range: 23-27/hr

Preparation/Recovery Technician

Prepares animals for surgery and provides immediate post-operative care, including anesthesia, intubation, IV placement, vital monitoring, specimen collection, pain assessment, medication administration, and recovery monitoring. Requires a scientific bachelor’s degree or veterinary technology associate degree

Starting Pay Range: 23-27/hr

Pathology Technician

Performs necropsies, gross examinations, tissue trimming, specimen shipping, imaging, study coordination, GLP documentation, and laboratory equipment maintenance and calibration. Requires an associate or bachelor’s degree or equivalent in Biological Sciences or a related field and three years of GLP nonclinical experience.

Starting Pay Range: 23-25/hr

Working Conditions:

•   While performing the duties of this job, the employee is regularly exposed to fluoroscopy, occasionally required to work within a Bio-Safety-Level 2 (BSL2) environment, and on rare occasions is exposed to faxitron x-ray imaging. The employee is required to wear protective lead clothing ranging in weight from 12 lbs. to 21 lbs. during all radiographic exposure. The employee is regularly exposed to, and must handle and come in contact with, a variety of livestock, domestic and laboratory animals, as well as their blood and body fluids. The employee regularly works with sharps, and gasses such as CO2 and isoflurane, and is occasionally exposed to wet conditions (non-weather), toxic or caustic chemicals, and zoonotic diseases.
•   The noise level in the work environment is usually moderate and occasionally loud. Hearing protection is required in designated areas and when performing specific tasks.
•   While performing the duties of this job, the employee is regularly required to stand, walk, use hands, and talk or hear. The employee is frequently required to reach with hands and arms, and to use hands and fingers to perform meticulous sutures, incisions, and other tasks The employee is occasionally required to sit, climb or balance, stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
•   Specific vision abilities required by this job include close vision, the ability to see a full range of colors, the ability to adjust focus, and exceptional spatial acuity and visual-kinesthetic coordination.

#LI-DNP

The compensation grade range for this position is:

$15.24 - $29.57

Hourly

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

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NAMSA

Current Open Positions