BD Nogales Norte
Overview
Regulatory Affairs Specialist role at BD Nogales Norte. The Regulatory Affairs (RA) Specialist will be responsible for the preparation and management of device/drug master files, technical dossiers and/or medical device dossiers in support of combination product submissions in both domestic and international markets. This role involves implementing regulatory strategies to support stand-alone device and combination product development efforts for platform growth and global expansion. Join a global medical technology company that values learning, growth and the development of its people. BD is committed to helping you become your best self and to creating an inclusive, growth-oriented culture. Responsibilities
Dedicated Regulatory Affairs core team member for platform team. Partner with and support pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination product approvals in US, EU, and other markets. Manage multiple projects with attention to detail for health authority submission and audit readiness. Perform regulatory impact assessments of changes related to design, improvements, and customer experience for timely execution and global compliance. Manage new or renewal of existing registrations within the platform and author regulatory files (e.g. master files, GSPR packages, medical device dossiers) and respond to health authority responses as needed. Review and assess product design/QMS documentation; review product labeling for regulatory compliance. Develop and maintain knowledge of applicable regulations and standards; perform regulatory/customer intelligence/watch; educate internal and external stakeholders. Develop expertise and interpret regulations and agency guidelines in areas of combination products and medical devices. Performs other duties as assigned. Required Qualifications
Understanding of medical device and pharmaceutical drug product regulations for registration and pathways. Ability to plan and schedule multiple priorities concurrently. Ability to review, collate and summarize scientific and technical data. Adaptable, problem-solver, multitasker in changing environments; strong written and oral communication skills. Detail-oriented, methodical, with high accuracy in regulatory information and submissions. Ability to work independently with minimal supervision. Excellent writing and strong organizational skills. Preferred Qualifications
Understanding of Combination Products regulations, product development cycle, clinical phases, change management and cGMP/quality management systems. Experience with CE Marking, Master Files and eCTD. Education And/or Experience
Bachelor’s degree or advanced degree in a technical discipline (e.g., pharmacy, biology, chemistry, engineering or medical-related field). Minimum of 2-3 years of Medical Device and/or Pharmaceutical Regulatory Affairs experience. Salary Range
$84,300.00 - $138,900.00 USD Annual Primary Work Location: USA NJ - Franklin Lakes Seniority level
Mid-Senior level Employment type
Full-time Job function & Industry
Job function: Legal Industry: Manufacturing Why Join Us
BD offers opportunities to learn, grow and contribute to a culture that values inclusion, accountability and continuous improvement. You will work with inspiring leaders and colleagues who are passionate about health and innovation. Visit BD Careers for more information: https://bd.com/careers Equal Opportunity Employment
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
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Regulatory Affairs Specialist role at BD Nogales Norte. The Regulatory Affairs (RA) Specialist will be responsible for the preparation and management of device/drug master files, technical dossiers and/or medical device dossiers in support of combination product submissions in both domestic and international markets. This role involves implementing regulatory strategies to support stand-alone device and combination product development efforts for platform growth and global expansion. Join a global medical technology company that values learning, growth and the development of its people. BD is committed to helping you become your best self and to creating an inclusive, growth-oriented culture. Responsibilities
Dedicated Regulatory Affairs core team member for platform team. Partner with and support pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination product approvals in US, EU, and other markets. Manage multiple projects with attention to detail for health authority submission and audit readiness. Perform regulatory impact assessments of changes related to design, improvements, and customer experience for timely execution and global compliance. Manage new or renewal of existing registrations within the platform and author regulatory files (e.g. master files, GSPR packages, medical device dossiers) and respond to health authority responses as needed. Review and assess product design/QMS documentation; review product labeling for regulatory compliance. Develop and maintain knowledge of applicable regulations and standards; perform regulatory/customer intelligence/watch; educate internal and external stakeholders. Develop expertise and interpret regulations and agency guidelines in areas of combination products and medical devices. Performs other duties as assigned. Required Qualifications
Understanding of medical device and pharmaceutical drug product regulations for registration and pathways. Ability to plan and schedule multiple priorities concurrently. Ability to review, collate and summarize scientific and technical data. Adaptable, problem-solver, multitasker in changing environments; strong written and oral communication skills. Detail-oriented, methodical, with high accuracy in regulatory information and submissions. Ability to work independently with minimal supervision. Excellent writing and strong organizational skills. Preferred Qualifications
Understanding of Combination Products regulations, product development cycle, clinical phases, change management and cGMP/quality management systems. Experience with CE Marking, Master Files and eCTD. Education And/or Experience
Bachelor’s degree or advanced degree in a technical discipline (e.g., pharmacy, biology, chemistry, engineering or medical-related field). Minimum of 2-3 years of Medical Device and/or Pharmaceutical Regulatory Affairs experience. Salary Range
$84,300.00 - $138,900.00 USD Annual Primary Work Location: USA NJ - Franklin Lakes Seniority level
Mid-Senior level Employment type
Full-time Job function & Industry
Job function: Legal Industry: Manufacturing Why Join Us
BD offers opportunities to learn, grow and contribute to a culture that values inclusion, accountability and continuous improvement. You will work with inspiring leaders and colleagues who are passionate about health and innovation. Visit BD Careers for more information: https://bd.com/careers Equal Opportunity Employment
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
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