12 days old

Regulatory Affairs Specialist

Aesculap Implant Systems
Center Valley, PA 18034
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  • Job Code
    113494061
Aesculap Implant Systems


Regulatory Affairs Specialist

US-PA-Center Valley

Job ID: 2019-15131
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory
Aesculap Implant Systems

Overview

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

  • 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.

Expertise: Knowledge & Skills

Secondary or peripheral job functions:

  • Performs special projects as assigned.
  • Supports FDA inspections and handles other regulatory compliance issues as necessary


Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

  • 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.

Desired:

  • N/A

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.

PI113494061

<b>Aesculap Implant Systems</b><br/><br/><br/><b>Regulatory Affairs Specialist</b><br/><br/>US-PA-Center Valley<br/><br/><b>Job ID:</b> 2019-15131<br/><b>Type:</b> Regular Full-Time<br/><b># of Openings:</b> 1<br/><b>Category:</b> Regulatory<br/>Aesculap Implant Systems<br/><br/><b>Overview</b><br/><br/><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif';">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. </span></p><br/><br/><b>Responsibilities</b><br/><br/><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Position Summary:</span></strong></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">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. </span></p><p style="margin: 0px;"> </p><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Responsibilities: Essential Duties</span></strong></p><ul><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Actively participates on cross functional teams and supports regulatory strategy development for new and modified medical devices.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Conducts research on product classification, predicate devices and other requirements necessary to support regulatory submissions.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Reviews verification / validation plans, protocols and reports, clinical evidence reports, preclinical testing such as in vivo animal studies and biocompatibility testing.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Coordinates, compiles, and submits 510(k)s, IDEs, PMA and postmarket reports. </span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Responds to FDA inquiries and requests for additional information. Negotiates with FDA to ensure timely approvals/clearances as necessary.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Provides Regulatory determinations for all new devices and modifications.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Writes letter to files as appropriate.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Supports postmarket activities required to launch new products (eg, load sheets)</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Reviews and approves product labeling including IFUs, surgical technique manuals, and marketing materials. </span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Provides support for import and export activities.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Participates in risk assessments as part of new product development team and field action decisions.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Assists in SOP development and review.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Assess and interpret regulatory requirements and their impact on the organization and/or products.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Must comply with applicable federal, state and local regulations as stated in the Quality Manual.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Must embody the Companys Vision, Mission and Values.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Other duties may be assigned by management.</span></li></ul><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Expertise: Knowledge & Skills</span></strong></p><p style="margin: 0cm 0cm 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Secondary or peripheral job functions:</span></p><ul><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Performs special projects as assigned.</span></li><li><span style="font-family: 'times new roman', times; font-size: 10pt;">Supports FDA inspections and handles other regulatory compliance issues as necessary</span></li></ul><br/><br/><b>Qualifications</b><br/><br/><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Expertise: Qualifications-Experience/Training/Education/Etc</span></strong></p><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Required:</span></strong></p><ul><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Bachelors Degree in a life science or engineering preferred. Equivalent work experience will be considered.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Five (5) years experience medical device Regulatory Affairs expected but minimum of three (3) years will be considered.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Must have experience authoring a minimum of three (3) 510(k) submissions or equivalent experience.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Must be able to organize work and manage multiple priorities.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Requires strong written, oral, communication skills required.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Must be detail-oriented and highly organized.</span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Analytical skills needed to conduct research, analyze data and write recommendations. </span></li><li><span style="font-size: 10.0pt; font-family: 'Times New Roman',serif;">Some domestic and international travel is required.</span></li></ul><ul><li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Language and mathematical skills; reasoning ability:</span></li><li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">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. </span></li><li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">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. </span></li><li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">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. </span></li></ul><p style="margin: 0cm 0cm 10pt;"><strong><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Desired:</span></strong></p><ul><li style="color: #000000;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">N/A</span></li></ul><p style="margin: 0cm 0cm 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">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.</span></p><p style="margin: 0cm 0cm 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">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. </span></p><p style="margin: 0cm 0cm 10pt;"><span style="font-family: 'Times New Roman','serif'; font-size: 10pt;">Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</span></p> <img src="https://analytics.click2apply.net/v/NaywoAUjMDlxSRBOuALVY"> <p>PI113494061</p>
Posted: 2019-09-06 Expires: 2019-10-08

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Regulatory Affairs Specialist

Aesculap Implant Systems
Center Valley, PA 18034

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