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.
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].
Previous experience with Premarket Approvals (PMAs) and Investigational Device Exemptions (IDEs) is desired.
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and
Additional Salary Information: 15% bonus and comprehensive benefits package.
A global leader with a U.S. focus providing leading healthcare solutions for over 170 years
B. Braun Medical Inc. (B.Braun) has global headquarters in Melsungen, Germany and operations in 64 countries. In the U.S., B.Braun’s corporate headquarters is located in Bethlehem, Pennsylvania with primary manufacturing facilities in Allentown, Pennsylvania and Irvine, California.
A leader in infusion th...erapy and pain management technology, products and services, B. Braun Medical Inc. (B. Braun) enables health care professionals to provide safer, more cost-effective and more environmentally responsible care.
Our global expertise combined with our Centers of Excellence (CoEs), which consolidate product line production in facilities around the world, enable us to realize efficiencies that we can pass on to our customers. Two CoEs in the U.S. include one for needle-free devices and one for infusion solutions.
Our U.S. organization is comprised of four divisions — Hospital Care, Original Equipment Manufacturing (OEM), Outpatient Markets (OPM), and Renal Therapies.