Project Manager I, RA

Project Manager I, RA

US-PA-Center Valley

Job ID: 2019-15493
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

• Serves as Regulatory Affairs lead on cross-functional product development project teams.
• Works with Marketing, R&D, MSA and QA to develop effective regulatory strategies.
• Facilitates the generation and provision of information for product submissions, and helps to drive the product development process.
• Reviews information (e.g. plans, protocols, reports) for suitability for submission.
• Drafts Letters-to-File, 510(k), De Novo, IDE and PMA submissions.
• Directly interacts and negotiates with FDA to ensure product clearances/approvals.
• Ensures the timely registration/clearance/approval of products.
• Resolves regulatory issues and develops solutions to a variety of problems of critical scope and complexity with little or no supervision.
• Supports post-approval activities.
• Reviews and approves labeling, packaging, advertising and promotional information for regulatory compliance.
• Provide regulatory input for product recalls and recall strategies.
• Anticipates regulatory obstacles and emerging issues throughout the product life-cycle and develops solutions with other departments.
• Actively participates in various industry groups (e.g. AdvaMed, OSMA, AAMI).
• Keeps abreast of and shares information of changes to the regulatory and competitive environment.
• Interacts with FDA, industry groups (e.g. AdvaMed, OSMA), corporate partners, customers and vendors.
• Assists RA staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances.
• Reviews submissions to the FDA.
• Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders.
• Oversees the review of product labeling, packaging, advertising and promotional information.
• Assists Quality Assurance with FDA inspections and internal/ external audits.
• Must comply with applicable regulations, as stated in Quality Manual.
• Must embody the Company’s Vision, Mission and Values.
• Other duties as assigned.

Secondary / peripheral job functions:

• Supports the Head of Regulatory Affairs, as required / when requested.
• Performs other duties or special projects as assigned by Regulatory Affairs Management/Leadership.
• Requires excellent written, oral and interpersonal communication skills.
• Computer skills in Windows, MS Word, Excel and Power Point.
• Must be able to travel by automobile, train and airplane, and work occasional weekends.

Supervisory Responsibilities:

• No direct supervisory responsibility. Provides coaching and mentoring to junior staff.
• May work in a supervisory role during absence of the Head of Regulatory Affairs.

Job Specifications:

Qualifications

Education/Experience:

• Bachelor of Science Degree in Engineering or Life Science -or- Associate of Science Degree Plus Significant Medical Device Regulatory Affairs Experience
• Minimum of 10 years of Regulatory Affairs experience in an FDA-regulated industry. Medical device industry experience highly preferred.
• Substantial experience directly interacting with the US FDA (e.g. meetings, negotiations).
• Practical knowledge of product development, product life cycle management, and design controls, medical device registration/clearance/approval, QSR and GMP desired.
• Practical experience with testing (e.g. bench testing, biocompatibility testing, etc.), spine and/or orthopedics desired.
• Regulatory Affairs Certification a plus. Project Management Certification a plus.
• Ability to anticipate changing regulations and business needs, and proactively work to change direction.
• Strong technical understanding of products, procedures, practices and associated medical terminology.
• Proficient in MS Office Suite. SAP experience preferred.
• Must be able to travel locally, domestically and internationally.

Language and mathematical skills; reasoning ability:

• Language Skills: Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies and/or members of the business community. Ability to effectively present information to executive management, public groups and/or boards of directors.
• Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• 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.

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