Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives. Responsibilities Position Summary:
The Regulatory Affairs Specialist must have a thorough understanding of FDA regulations and the medical device product lifecycle with a strong emphasis on the technical aspects of Regulatory Affairs project management. The position is responsible for assisting with Regulatory strategy for new / modified medical devices, preparation and review of regulatory submissions. The position requires strong organizational and communication skills. The Regulatory Affairs Specialist is expected to have experience interacting and negotiating with regulatory authorities in order to ensure timely product approvals. Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Actively participates on cross functional teams and supports regulatory strategy development for new and modified medical devices.
- Conducts research on product classification, predicate devices and other requirements necessary to support regulatory submissions.
- Reviews verification / validation plans, protocols and reports, clinical evidence reports, preclinical testing such as in vivo animal studies and biocompatibility testing.
- Coordinates, compiles, and submits 510(k)s, IDEs, PMA and postmarket reports.
- Responds to FDA inquiries and requests for additional information. Negotiates with FDA to ensure timely approvals/clearances as necessary.
- Provides Regulatory determinations for all new devices and modifications.
- Writes letter to files as appropriate.
- Supports postmarket activities required to launch new products (eg, load sheets)
- Reviews and approves product labeling including IFUs, surgical technique manuals, and marketing materials.
- Provides support for import and export activities.
- Participates in risk assessments as part of new product development team and field action decisions.
- Assists in SOP development and review.
- Assess and interpret regulatory requirements and their impact on the organization and/or products.
- Must comply with applicable federal, state and local regulations as stated in the Quality Manual.
- Must embody the Company's Vision, Mission and Values.
- Other duties may be assigned by management.
Secondary or peripheral job functions:
Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required:
- Performs special projects as assigned.
- Supports FDA inspections and handles other regulatory compliance issues as necessary
- Bachelor's Degree in a life science or engineering preferred. Equivalent work experience will be considered.
- Five (5) years experience medical device Regulatory Affairs expected but minimum of three (3) years will be considered.
- Must have experience authoring a minimum of three (3) 510(k) submissions or equivalent experience.
- Must be able to organize work and manage multiple priorities.
- Requires strong written, oral, communication skills required.
- Must be detail-oriented and highly organized.
- Analytical skills needed to conduct research, analyze data and write recommendations.
- Some domestic and international travel is required.
- Language and mathematical skills; reasoning ability:
- Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Other Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands:
The physical demands described here are representative of those that 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 the essential functions. Work Environment:
- This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
One of the world's leading healthcare suppliers.