ZipRecruiter

Log In

1

Associate Medical Device Labeling Jobs in Georgia

VIVEX BIOLOGICS INC

Director of Regulatory Affairs

Atlanta, GA · On-site

$142K - $188K/yr

... medical device applications in addition other various submissions to regulatory agencies. This ... labeling, corporate and public communications and materials. 2. Manage supplier and distributor ...

Intellectt INC

Packaging Operator

Grayson, GA · On-site

$15.75 - $19/hr

The tasks required of this position include but are not limited to mixing formulation by performing accurate measurements of chemicals into water solutions, packing out medical device kits, labeling ...

millenniumsoft

Laboratory Technician

Covington, GA · On-site

$16 - $21.50/hr

Education And/Or Experience • Minimum of Associate degree required. Engineering or science area major preferred. • Minimum of 2-4 years of related experience in medical device, pharmaceutical or ...

Pacer Group

Operator 1, Packaging Operations

Grayson, GA · On-site

$15.75 - $19/hr

The tasks required of this position include but are not limited to mixing formulation by performing accurate measurements of chemicals into water solutions, packing out medical device kits, labeling ...

Integer

Manufacturing Team Member

Trenton, GA

$10 - $13/hr

... Medical device and Military markets. Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base wages ...

Integer

Manufacturing Team Member

Trenton, GA

$10 - $13/hr

... Medical device and Military markets. Other : Proficient in assembly operations. Work is closely supervised. Our total rewards program is designed to attract, retain, and motivate associates to ...

SQA Services

Quality Auditor - Animal Food

Cumming, GA · Remote

$1K/day

Our associates are expert quality assurance professionals with extensive experience and local ... medical device, cosmetics, and/or animal health industries * Coordinate, prepare, execute, and ...

SQA Services

Quality Auditor - Animal Food

Atlanta, GA · Remote

$1K/day

Our associates are expert quality assurance professionals with extensive experience and local ... medical device, cosmetics, and/or animal health industries * Coordinate, prepare, execute, and ...

IQVIA

MedTech Field Service Engineer

Atlanta, GA

$27 - $32/hr

You will have an opportunity to travel, grow, and expand into new opportunities while earning supplemental income and learning the medical device industry. Job Requirements: * Associate degree, or ...

IQVIA

MedTech Field Service Engineer

Atlanta, GA

You will have an opportunity to travel, grow, and expand into new opportunities while earning supplemental income and learning the medical device industry. Job Requirements: * Associate degree, or ...

next page

Showing results 1-20

All JobsAssociate Medical Device Labeling JobsAssociate Medical Device Labeling Jobs in Georgia

Associate Medical Device Labeling information

What are some common challenges faced by Associate Medical Device Labeling professionals, and how can they be addressed?

Associate Medical Device Labeling professionals often encounter challenges such as keeping up with evolving regulatory requirements across different countries, ensuring accuracy and clarity in complex technical information, and coordinating input from multiple departments like regulatory affairs, engineering, and marketing. Addressing these challenges involves staying updated on global labeling standards, developing strong attention to detail, and building effective communication and collaboration skills. Leveraging project management tools and regularly participating in training can also help manage these complexities and ensure timely, compliant labeling deliverables.

What are Associate Medical Device Labeling professionals?

Associate Medical Device Labeling professionals are responsible for creating, reviewing, and maintaining the labeling and packaging materials for medical devices. Their work ensures that all product information, instructions, and regulatory warnings are accurate, clear, and compliant with industry regulations. They collaborate closely with regulatory affairs, quality assurance, and product development teams to make sure that labels meet local and international standards. This role is critical in helping ensure patient safety and regulatory approval of medical devices.

What are the key skills and qualifications needed to thrive as an Associate Medical Device Labeling Specialist, and why are they important?

To thrive as an Associate Medical Device Labeling Specialist, you need a strong understanding of regulatory requirements, attention to detail, and experience in technical writing, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document management systems, and knowledge of FDA or EU MDR regulations are typically required. Excellent communication, collaboration, and organizational skills set top performers apart in this position. These skills are crucial to ensure label accuracy, regulatory compliance, and patient safety in a highly regulated industry.
Associate Medical Device Labeling jobs near you
Director of Regulatory Affairs

Director of Regulatory Affairs

VIVEX BIOLOGICS INC

Atlanta, GA • On-site

$142K - $188K/yr

Full-time

Posted 15 days ago

Job description

Description:

The Director of Regulatory Affairs will be responsible for the coordination, compilation and submission of biologics and medical device applications in addition other various submissions to regulatory agencies. This person will be responsible for developing and implementing Chemical and Manufacturing Controls (CMC). This role will also provide guidance to project teams on the current regulatory framework from the Food and Drug Administration (FDA) to ensure the added value to the business from the commercialization of medical products. The Director of Regulatory Affairs will be responsible for managing supplier and distributor qualifications and the company’s auditing program as well as maintaining voluntary accreditations, state licenses and establishment registrations and listings.

Requirements:

Duties and responsibilities

1. Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials.

2. Manage supplier and distributor qualifications and the organization’s internal and external auditing program.

3. Work with multidisciplinary teams on the commercialization to ensure compliance with FDA regulations including:

a. Coordination, compilation, and submission of regulatory filings including but not limited to: Requests for Designation (RFD), Investigational New Drug (IND), Biologics License Application (BLA), 510(k), and Pre-Market Approval (PMA).

b. CMC development and implementation

c. Support of clinical trial protocol development

4. Oversee and maintain licensing, registration, and accreditation with the different state, federal, and independent regulatory bodies.

5. Support and maintain regulatory reporting endeavors including but not limited to MedWatch and Biological Product Deviations.

6. Remains current trends in industry and practices up to and including association memberships with committee or work group participation. Identifies patterns to improve processes. Assists in the development and improvement of policies and procedures for all aspects of business, to include data collection and regulatory compliance.

7. Performs other related duties as assigned.


Qualifications

Education Required: Bachelor of Science or Arts in a relevant discipline is required.

Experience: Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred.

Licenses/Certifications: AATB CTBS, ASQ, or other allied health licensure or certification preferred.


Working conditions

Office, processing plant work, travel by air, train, & car. Some evening and weekend work required to ensure company commitments and goals are met.


Physical requirements

While performing the duties of this job, the employee is regularly required to sit; stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.


Direct reports

Regulatory Affairs Manager, Audit Program Supervisor



Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.


Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.


Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.