Requisition ID 2018-12553 Company Aesculap Implant Systems # of Openings 1 Job Locations US-PA-Center Valley Category Regulatory Position Type Regular Full-Time Shift 8 a.m. to 5 p.m. Site Aesculap Implant Systems
Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients' lives.
Responsible for directing and executing all Regulatory Affairs (RA) activities of the company to assure compliance to applicable laws and regulations of the State and Federal governments related to obtaining product approval and maintaining product marketing rights. Plans and directs the organization's regulatory policies.
Responsibilities: Essential Duties
Formulate and implement regulatory affairs policies and procedures to ensure that full regulatory compliance with FDA and standard protocols is maintained or enhanced.
Directs regulatory requirements and regulatory strategy on product development to ensure timely submission and approval.
Review new medical device submissions made to the FDA for market clearance.
Review and make final determinations for regulatory assessments of proposed changes to existing products.
Obtain regulatory verification and confirm strategy with outside legal counsel.
Read, review, interpret and keep current with local, regional, and national regulations and publications regarding medical devices.
Interact with representatives of domestic and international partner companies and international regulatory authorities as needed to discuss regulatory issues and submission requirements.
Interact with the US Food and Drug Administration (FDA) and other domestic and international regulatory agencies concerning specific domestic filings.
Provide guidance on regulatory requirements to cross functional departments.
Assist FDA inspectors during any pre-approval inspections or audits covering Aesculap regulatory submissions.
Manages RA staff in accordance with the company's policies and applicable laws.
Develops corporate regulatory submission strategies for new product lines and major changes to existing products to ensure timely product clearance/approval.
Plans department's projects and develop budgets for the department.
Gathers necessary information for inclusion into product submissions. Writes 510(k)'s or PMA's and follows up with FDA to ensure approval.
Organizes and prioritizes assignments for RA group.
Supports the review of case report forms, protocols, instructions for use, study operations manuals, site and FDA annual reports.
Develops and maintains relationships with outside consultants and vendors as required
Estimates product needs with management approval, initiates supply management process.
Assists in preparation of regulatory submissions to FDA.
Keeps abreast of FDA events and competitive products.
Assists in development of product labeling, packaging, promotion, etc.
Reviews legal documents and federal regulations and interprets essential elements for application for Aesculap, Inc.
Resolves regulatory issues and problems. Recommends appropriate courses of action to executive management as necessary.
Leads FDA inspections. May escort investigator and address inquiries.
Performs special projects assigned
Must comply with applicable ISO and FDA regulations as stated in Quality Manual
Must embody the Company's Vision, Mission and Values
Other duties may be assigned
Expertise: Knowledge & Skills
Secondary or peripheral job functions:
Oversees Regulatory Affairs employees in accordance to company policies and applicable laws.
Must be able to travel domestically and internationally by air and car, and work occasional weekends. Must posses a valid government issues drivers license and passport.
Bachelor's degree from accredited college in pharmacy, biology or related field of science, Master's or Ph.D. in related science degree desired.
At least 15 years of experience in Regulatory Affairs with a medical device manufacturing organization.
10 years management and leadership experience.
Substantial experience in direct interaction with FDA such as making presentations on proposed submissions and negotiating submission requirements where appropriate.
Experience in analyzing and developing strategies for regulatory submissions to assure timely approval.
Excellent interpersonal skills and the ability to work and manage effectively in a team environment.
Must have significant experience with the preparation, submission, and FDA interface and negotiation for Investigational Device Exemption and Premarket Approval applications.
Highly organized with the ability to manage complex projects.
Professional certification (RAC) is highly desirable.
Must be able to organize work and manage multiple priorities.
Possess the analytical skills needed to conduct research, analyze data and write technical and/or legal documents.
Requires excellent written and interpersonal communication skills.
Computer skills in Windows, Lotus e-mail, Excel, Power Point and work processing desirable. SAP experience highly desirable.
Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
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 50 pounds.
Responsibilities: Other Duties:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands:
The employee must occasionally lift and/or move up to 50 pounds.
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.
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 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.