Aesculap Implant Systems
Aesculap Implant Systems
Sr. Regulatory Affairs Spec.
Job ID: 2021-17613
Type: Regular Full-Time
# of Openings: 1
Aesculap Implant Systems
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.
This position is responsible for developing regulatory strategies for new / modified medical devices, preparation of market applications, and review of regulatory documentation/strategies.
Responsibilities: Essential Duties
- Develops regulatory strategies for product registration to ensure early product approval.
- Gathers and researches the necessary information for inclusion into product applications. Writes 501(k)'s IDE'S, PMA'S and follows up with FDA to ensure clearances / approval. Resolves regulatory issues and develops solutions to a variety of problems of moderate scope and complexity.
- Keeps abreast of FDA events and competitive products.
- Lists products with the FDA listing Branch. Responds to FDA inquiries regarding product listings.
- Participates in the development, review and approval of product labeling.
- Reads legal documents and federal regulations and interprets essential elements for application to Aesculap.
- Audits regulatory records and reports.
- Communicates through written and oral means; in face to face contact, meetings and phone discussions.
- Writes technical documents.
- Supports postmarket activities required to launch new products (eg, load sheets)
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Assimilates information from a variety of sources and organize information into a logical, presentable format.
- Works under minimal supervision, with benefit of previous regulatory experience.
- Reads drawings/blueprints.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
Expertise: Knowledge & Skills
Secondary or peripheral job functions:
- Performs other duties or special projects as assigned by the manager of this position.
- Makes travel plans and schedule meetings, as necessary
- May participate in back room during an FDA inspections
Supervisory Responsibilities: N/A
- Bachelor's degree in life sciences or related field, preferred with 5-7 years' experience or a minimum of 12 years equivalent work experience in the Regulatory environment.
- Must have experience authoring a minimum of ten (10) submissions or equivalent experience
- Professional certification(s) highly desirable (RAC Certification)
- Knowledge of US Medical Device law, Quality Systems Regulations and compliance.
- Able to analyze and develop strategies for regulatory submission with minimal supervision.
- PC experience is required and proficiency in Office, Adobe, SAP, etc.
- Requires strong written, oral, interpersonal, group, and telephone communication skills.
- 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.
- Organizes work and juggles multiply priorities; organize thought processes.
- Ability to work and problem solve both independently and within a team.
- 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.
B. 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.
Through its "Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Preferred Years Of Experience:12 Year(s)
Education Required:4 Year Degree - BA
Employment/Position Type:Full Time
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