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BD (Becton, Dickinson and Company) Senior Staff Regulatory Affairs Specialist (Remote Optional) in Franklin Lakes, New Jersey

Job Description SummaryThe Senior Staff Regulatory Affairs Specialist will work in BD Integrated Diagnostic Solutions – 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 develop and execute regulatory strategies to support new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities. The position is responsible for supporting and/or leading key regulatory initiatives to drive process improvements and efficiencies. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU. The role may be responsible for supervising 1-2 associates.

Job Description

  • Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, 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, with input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).

  • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, andproviding measurable regulatory guidancethroughout the product development cycle priorto regulatory submission.

  • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to partners.

  • Support development and execution of global regulatory strategies by working closely withinternational regulatory associatesto register our devices worldwide.

  • Mentor other RA specialists in development of RA strategies and reviews/approves their work.

  • Lead regulatory efforts required to align with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.

  • Review and approve product labeling, promotional materials, and advertising materials toensure regulatory compliance.

  • Review clinical and human factors protocols/reports to assure collection of appropriate datafor regulatory submissions and regulatory compliance. Engages with Medical Affairs in the development and approval of Clinical Evaluation Report) to assure the documents meet regulatory requirements.

  • Ensures FDA device listings and facility registrations are maintained.

  • Request FOI information and maintain FOI files in alignment with business strategies.

  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

  • Coordinate and respond to requests for product information, and questionnaires requested by customers.

  • Represent BD in relevant external trade organizations and regulatory standards development as needed to support BD’s ongoing product development and compliance efforts.

  • Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors advised about potential impact.

  • Identify ways to improve the efficiency of current work process and execute them.

  • Carry out the above tasks without supervision.

Qualifications:

  • B.S. degree in a technical subject area (e.g., engineering, bioengineering, biology, chemistry). Advanced degree preferred.

  • Minimum 7years Regulatory Affairs experiencein medical device or in vitro diagnostic device companies or 5 years if proven experience with an advanced degree.

  • Proven track record to resolve problems and to make appropriate regulatory decisions under pressure.

  • Proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies.

  • Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.

  • International product registration experience preferred.

Knowledge, Skills, and Abilities:

  • Proficient in using Microsoft Word, Excel, PowerPoint, and Project.

  • Strong communication (written, oral) and project management skills.

  • Able to handle multiple competing tasks with attention to detail.

  • Strong critical thinking skills.

  • Able to work independently to achieve objectives on or before schedule.

  • Demonstrated global perspective, customer-focused, cross-functional teamwork and partnership skills.

  • Extensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.

  • Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDD 98/79/EC. Knowledge of EU MDR and IVDR preferred.

Why join us?

A career at BD means joining a team that values your opinions and contributions and that encourages you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally hardworking and committed to encouraging an inclusive, growth-centered, and exciting environment. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is crafted to support the varying needs of our diverse and global associates.

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To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work ShiftNA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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