Regulatory Affairs Specialist, Labeling

Exactech, Inc.
Job Description

Job Details

Description

Purpose:

This office position is responsible for leading medical device labeling projects (including, but not limited to product labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market Exactech Inc. products. It requires demonstrated leadership and communication skills, as well as a broad understanding of label and IFU development, change management systems/procedures/concepts, and labeling systems.

Duties and Responsibilities (Key Deliverables):

1. Serve as the Global Labeling core team member for Exactech Inc. labeling initiatives, including but not limited to NPD (new product development), maintenance projects, and UDI tasks. 

2. Commitment to learn and stay abreast of global medical devices regulatory requirements.

3. Work with Regulatory, Engineering and Development, Packaging, and other departments to develop/create labeling that complies with worldwide regulations and requirements.

4. Initiate change requests for new and revised labeling, work with Labeling team to create, maintain, and implement compliant labeling, review product labeling against indicated content, and approve/release labeling.

5. Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverables.

6. Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.

7. Demonstration of strong problem-solving skills; able to analyze all variables in a situation, identify potential solutions, and implement the best solution in a timely manner.

8. Good understanding of how labeling systems communicate with other business systems

9. Exceptional attention to detail, organization, and multi-tasking skills.

10. Commitment to learn and stay abreast of medical devices regulations.

11. Understanding of the orthopedic industry, and the marketplace.

12. Know and apply the Quality System and any appropriate Federal and International standards. 

13. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education: Bachelor’s Degree in a related field from an accredited institution required.

Experience:

• Minimum 2 years of experience in FDA / ISO medical device quality management system standards required

• 2 years’ experience in in FDA pre-market submissions (510(k) and/or PMA) and international product registrations preferred

• Technical writing Skills required

• Experience with Design Controls.;

Functional/Technical Knowledge, Skills and Abilities Required:

• Experience with labeling software, such as enLabel or Prisym preferred.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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