Sr. Staff Regulatory Affairs Specialist

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Location :
Franklin Lakes, New Jersey

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Job Description Summary Job Description Job Description Senior Staff Regulatory Affairs Specialist is responsible for creating and executing regulatory strategies and objectives in alignment with business needs. This includes the preparation of regulatory submissions required to market new or modified medical devices in the U.S. and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical and human factors studies, addresses all regulatory requirements as well as the objectives of the business. – Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. – Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans. – Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies. – Prepares and submits US 510(k) submissions. – Identifies and communicates potential risks and mitigations associated with reg. strategies. – Coordinates interactions/negotiations with U.S. regulatory agencies. – Participates in internal/external trade, professional, and standards development organizations. – Reviews and approves labels, labeling, and promotional materials. – Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions. – Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. – Monitors worldwide regulatory developments (standards, guidance documents) and communicates emerging opportunities/concerns impacting BU products. – Carry out the above tasks without supervision. SPECIFIC SKILLS & ABILITIES: – Ability to read, analyze, and interpret regulatory literature and documents. – 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-centered, cross-functional collaboration, 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. MINIMUM QUALIFICATIONS: – Bachelors degree in a technical subject area (e.g., engineering, bioengineering, biology, chemistry). Advanced degree preferred. – Minimum of 5 years of Regulatory Affairs experience in medical device. – Proven success in the preparation and completion of regulatory 510(K) submissions to FDA and other global regulatory agencies. – Experience in negotiating with the FDA personnel in medical device area. – Ability to prioritize effectively and organize complex information. 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. #LI-PRO Primary Work LocationUSA NJ – Franklin Lakes Additional LocationsUSA CA Brea Work Shift