[Hiring] Staff Regulatory Affairs Specialist @BD

Role Description

In BD – Specimen Management (BD SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our Staff Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing PreAnalytiX and Lab Specimen Management product portfolios, in addition to opportunities to provide regulatory support for new product development projects. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team.

The Staff Regulatory Affairs Specialist will work in BD – Specimen Management providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. The incumbent will support product lifecycle management activities for PreAnalytiX and Lab Specimen Management products, including assessment of the regulatory impact of product changes and line extensions. The incumbent may also develop and execute regulatory strategies to support new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities.

• Coordinate, prepare, and complete premarket applications to the US FDA, including Premarket Notification [510(k)], Pre-Sub, and De Novo submissions in a timely manner.
• Act as liaison with FDA regarding product submissions.
• Assess necessity for submitting a 510(k) application for proposed device modifications.
• Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
• Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products.
• Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements.
• Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies.
• Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities.
• Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements.
• Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates.
• Lead regulatory efforts that are required to follow new regulations (e.g., EU MDR/IVDR, MDSAP).
• Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
• Coordinate and respond to requests for product information, and questionnaires requested by customers.
• Ensure FDA device listings and facility registrations are maintained.
• Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
• Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities.
• Identify ways to improve the efficiency of current work processes and implement them.

Qualifications

• B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry).
• 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
• Proficient in Technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
• Experience maintaining confidentiality in dealing with regulatory and clinical documentation.
• Experience with cross-functional collaboration and teamwork skills including influencing without authority.
• Proficient in using Microsoft Word, Excel, PowerPoint.

Requirements

• Advanced Degree.
• Current knowledge of the U.S. and European medical device regulations.
• Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global regulatory agencies.
• Ability to provide regulatory support through the product life cycle on cross-functional product project teams.
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Familiarity with STED and/or technical file updates for CE marking activities and notified body interactions.
• Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical devices and in vitro diagnostic areas.

Benefits

• Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
• Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
• Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
• Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.