Sr. Regulatory Affairs Specialist - Medical Devices + 510K

B. Braun Medical Inc Located in: Allentown,  Pennsylvania, North East
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JOB DESCRIPTION

Position Summary:

To ensure marketing approval of B. Braun’s device products in the US and in foreign countries. To be a regulatory liaison with the FDA, Health Canada, other regulatory agencies as well as with internal cross functional departments and international RA colleagues for product development and changes to existing products. To perform job tasks independently and provide regulatory strategy.

 Responsibilities: Essential Duties

  • Prepare and submit Premarket Notifications [510(k)s], Investigational Device Exemptions (IDEs), and Premarket Approvals (PMAs).
  • Prepare and submit Canadian Device License Applications.
  • Prepare and submit Design Dossier and Technical Files for Europe.
  • Prepare and submit PMA supplements, PMA annual reports, and post market surveillance reports.
  • Review and approve product labeling and advertising.
  • Review change control documents for compliance with regulatory submissions requirements.
  • Coordinate and participate in routine FDA communications (including conference calls, written Correspondence and meetings).
  • Prepare regulatory assessments for new products and changes to existing products to determine the appropriate regulatory pathway to market.
  • Provide regulatory strategy, guidance and support as needed to Sales, Marketing, R&D, OEM, International, Engineering, Quality and Manufacturing.
  • Review and keep current with FDA regulatory requirements and trade publications.
  • Prepare written updates to management regarding status of regulatory tasks.

Expertise: Knowledge & Skills

  • Must possess knowledge of domestic (FDA) and foreign regulatory requirements for the manufacture and distribution of medical devices.
  • Must have working knowledge of the regulatory requirements for content and format of Premarket Notifications [510(k)s]. Knowledge of Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs) requirements is also desirable.
  • Must have working knowledge of Microsoft Windows software; Word, Excel, Access and PowerPoint.
  • Technical writing, computer literacy, review and analyze reports and data.
  • Must be able to communicate effectively (verbal and written) with governmental agencies and internal and external customers.
  • Must be able to meet deadlines, prioritize work, take the initiative to follow-up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently.

CRITICAL REQUIREMENTS

  • Must have medical device and 510K experience. Domestic.

    Required:


              
    • Bachelor of Science degree (4-year degree) or equivalent work experience is required.

    •         
    • Specific regulatory experience and experience in the medical device/pharmaceutical industry is required.

    •         
    • Three to five years of experience in preparing and submitting Premarket Notifications [510(k)s].

    Desired:


              
    • Previous experience with Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs) is desired.

    •         
    • Additional Requirements:

    •         
    • International business travel is required.

    •         
    • Driver's license is required.

    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. ver’s license is required.

     

COMPANY INFORMATION

About B. Braun Sharing Expertise® One of the biggest challenges facing health care providers today is enhancing safety and patient care while managing workflow efficiencies. As a division of the 13th largest global medical device manufacturer, B. Braun Medical Inc. (B.Braun) is uniquely poised to address this challenge. Guided by our Sharing Expertise® philosophy, B.Braun leads the way in developing infusion therapy and pain management products and services that meet the highest standards for quality, safety, sustainability and efficiency.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Regulatory Affairs
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
92,000 To 110,000 USD PER year
Bonus:
10%
Benefits:
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition re
Other Compensation:
Education Required:
Any
Class of Device:
Class 2