Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level, participating in cross-functional teams. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. In this role, the regulatory affairs specialist will provide global regulatory support for Abbott Vascular's medical device products , which may include regulatory submissions, existing product maintenance and new product development. Qualifications: This position does not require previous regulatory experience, but it is strongly preferred. 2-3 years experience in a regulated industry (e.g., medical devices, pharmaceuticals) is required. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Additional Knowledge and Responsibilities: Regulatory history, guidelines, policies, standards, practices, requirements and precedents. Regulatory agency structure, processes and key personnel. Principles and requirements of applicable product laws. Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs). Principles and requirements of promotion, advertising and labeling. Domestic and international regulatory guidelines, policies and regulations. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Write and edit technical document.s Negotiate internally. Pay strong attention to detail. Manage projects. Create project plans and timelines. Think analytically and critically. Organize and track complex information. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on the business. Apply business and regulatory ethical standards.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Position can be filled at RA Specialist level depending on experience. Primary Job Function As an individual contributor; the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed; obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. Core Job Responsibilities Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: • Assist in SOP development and review • Provide regulatory input to product lifecycle planning • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes • Understand; investigate and evaluate regulatory history/background of class; disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval • Determine trade issues to anticipate regulatory obstacles • Determine and communicate submission and approval requirements • Participate in risk-benefit analysis for regulatory compliance • Assess the acceptability of quality; preclinical and clinical documentation for submission filing • Compile; prepare; review and submit regulatory submission to authorities • Monitor impact of changing regulations on submission strategies • Monitor applications under regulatory review • Monitor and submit applicable reports to regulatory authorities • Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval • Maintain annual licenses; registrations; listings and patent information • Assist compliance with product postmarketing approval requirements • Review and approve advertising and promotional items to ensure regulatory compliance • Assess external communications relative to regulations • Review regulatory aspects of contracts • Assist with label development and review for compliance before release • Submit and review change controls to determine the level of change and consequent submission requirements • Analyze the input of cumulative product changes to current product submissions • Contribute to the development and functioning of the crisis/ issue management program • Ensure product safety issues and product-associated events are reported to regulatory agencies • Provide regulatory input for product recalls and recall communications Supervisory/Management Responsibilities Individual may provide direction and guidance to exempt and/or skilled non-exempt levels of employees. Also may be asked to evaluate performance of and assist in career development planning. Position Accountability/Scope Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues; and must assure that deadlines are met. Effectively communicate; prepare; and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Work is reviewed upon completion for adequacy in meeting objectives. Individual is recognized as an expert in work group. Minimum Education Bachelor's degree (or equivalent); Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience/Training Required 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years experience in a regulated industry (e.g., medical products, nutritionals).
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Description Primary Function Promotes Abbott Vascular products through education of current and potential customers and procedure coverage within a defined territory/region/area by providing clinical education and sales support in order to assist in achieving projected sales goals and increasing sales revenues within assigned product lines. Travel Required 50-75% Main Responsibilities 1. Serves as primary resource for clinical support in the areas of surgical coverage, troubleshooting and in-service education for company products. 2. Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to keep all customers abreast of the latest product, therapy, and technology developments and current items of interest in the industry. 3. Performs clinical and library research and participates in case reviews and clinical observation by working with physicians and/or lab staff. 4. Attends clinical procedures in the labs and operating rooms of hospital accounts to assure customer and patient success with Abbott Vascular products. 5. Meets with existing and potential clients (e.g., physicians, physician office groups at hospitals) by traveling (in an automobile or airplane) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how Abbott Vascular products can help them to achieve their goals. 6. Develops relationships with hospital personnel (e.g. through casual conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and to identify key decision makers in order to facilitate future sales. 7. Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical research, marketing, technical support) to develop optimal solutions. Accountability / Scope / Budget (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management. (Planning/Organization) Plans, organizes, and prioritizes own daily work routine to meet established schedule. (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources. Qualifications Bachelor's degree plus 6+ years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience. Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment. May be filled at another level depending on experience.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Description A Senior Development Quality Engineer provides ownership of the Design Control deliverables required to support both new product development projects and design change projects Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities Lead Risk Management activities from product Concept through Commercialization Support design test and inspection method development, and lead method validation activities Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps Support and ensure internal & external audit responses and on-time product re-certifications Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications Accountable for development, execution and analysis of biocompatibility and sterilization qualifications Develop and lead other team members Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Performs other related duties and responsibilities, on occasion, as assigned Additional Job Description Bachelor level degree in Engineering or Technical Field; advanced degree preferred 5+ years Quality engineering experience with new product development and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred ASQ CQE certification preferred Design for Six Sigma and Critical to Quality training and experience preferred Experience working in a broader enterprise/cross-division business unit model preferred Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Multitasks, prioritizes and meets deadlines in timely, proactive manner Strong organizational and follow-up skills, as well as attention to detail Ability to travel approximately 10%, including internationally Ability to maintain regular and predictable attendance