Senior Regulatory Specialist job opportunity at Abbott.

Home Jobs In United States Of America Tag: Job Senior Regulatory Specialist position at Abbott


DatePosted 24 Days Ago bot
Abbott Senior Regulatory Specialist
Experience: 16-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation United States - California - Pleasanton, United States Of America
loacation United States ..........United States Of America

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 114,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: Working at Abbott   At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.   You’ll   also have access to:   Career development with an international company where you can grow the career you dream of   Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.   An excellent retirement savings plan with high employer contribution   Tuition reimbursement, the   Freedom 2 Save   student debt   program   and   FreeU   education benefit - an affordable and convenient path to getting a bachelor’s degree   A company recognized as   a great place   to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune   A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists   Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to   monitoring   and treatment.   The Opportunity   This   Senior Regulatory Affairs Specialist   will work out of o ur Pleas a nton , CA location in the   Heart Failure   Division. As an individual contributor   in   the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department .   With limited   supervision   you will execute tasks and partner across business functions.   As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.     What   You’ll   Work On     • As the Experienced professional in the Regulatory Affairs Sub-Function,   possesses   well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.   • Interacts with   FDA and other   regulatory agency to   expedite   approval of pending registration.   • Serves as   regulatory   liaison throughout product lifecycle.   •   Participates   in some of the following: product plan development and implementation, regulatory strategy, risk management,   • Ensures   timely   approval of   medical devices and continued approval of marketed products.   • Interfaces directly with FDA and other regulatory agencies.   • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.   • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.   • Creates,   reviews   and approves engineering change orders.   • Reviews protocols and reports to support regulatory submissions.   • Supports all business segment initiatives as   identified   by divisional 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) and international 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.   • Serves as regulatory representative to marketing, research   teams   and regulatory agencies.   • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling,   appropriate regulations   and interpretations.     Required Qualifications    Bachelors   Degree (± 16 years) Technical discipline highly   preferred   OR a n equivalent combination of   education and work experience   Minimum 5 years   Technical   experience, including at least 4 years of regulatory experience in a medical   d evice industry.   Experience with 510(k) applications, PMA   supplements   and US device regulations and/or     experience with EU and other international medical device regulations and submissions.   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.     Stron g verbal and written communication with   ability   to effectively communicate at multiple levels in the   organization .   Multitasks,   prioritizes   and meets deadlines in   timely   manner.     Strong   organization   and follow-up skills, as well as attention to detail.   Ability to travel approximately 5%, including   internationally.     P referred Qualifications    Masters   Degree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory   experience.Minimum   3 years, 3-4   years experience   in a regulated industry (e.g., medical products,   nutritionals ). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related   area . Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society .)   Experience with review of labeling, promotional, and or advertising materials is highly desired   Familiar with   Principles and requirements o f   promotion,   a dvertising   and labeling.   Office program skills   to include   Word, Excel, PowerPoint, Adobe   Acrobat   and SharePoint.   Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields .    Master’s Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.         The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Regulatory Operations       DIVISION: HF Heart Failure          LOCATION: United States > Pleasanton : 6101 Stoneridge Dr       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Yes, 5 % of the Time       MEDICAL SURVEILLANCE: No       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)       Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.       EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf       EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Other Ai Matches

Key Account Manager - Hospicare - Kolkata Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Operator - Packaging (6:30p - 7:00a, rotating weekends_ Applicants are expected to have a solid experience in handling rotating weekends_ related tasks
Controls & Compliance Supervisor - CFS Americas Hub Applicants are expected to have a solid experience in handling Job related tasks
HCM - Giám sát Tiếp thị kênh GT (PG Sup) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Therapy Business manager - Ambala - GI Prospera Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Engineer II Applicants are expected to have a solid experience in handling Job related tasks
Hardware Engineer II Applicants are expected to have a solid experience in handling Job related tasks
Sr. Sales Specialist-Hospital Applicants are expected to have a solid experience in handling Job related tasks
HBO internship: Customer Service and Transport Applicants are expected to have a solid experience in handling Job related tasks
Global Product Manager Applicants are expected to have a solid experience in handling Job related tasks
Director US Marketing- TAVI Applicants are expected to have a solid experience in handling Job related tasks
MES Engineer II, Manufacturing Applicants are expected to have a solid experience in handling Manufacturing related tasks
Sr. Clinical Specialist - Cleveland, OH Applicants are expected to have a solid experience in handling OH related tasks
Omnichannel Seller Development Manager Applicants are expected to have a solid experience in handling Job related tasks
Technical Application Specialist Applicants are expected to have a solid experience in handling Job related tasks
Project Lead Applicants are expected to have a solid experience in handling Job related tasks
Clinical Associate Applicants are expected to have a solid experience in handling Job related tasks
Principal Clinical Specialist Applicants are expected to have a solid experience in handling Job related tasks
Senior Nutrition Sales Executive - Sambalpur Applicants are expected to have a solid experience in handling Job related tasks
Business Development Manager - Rapid Diagnostics (South Central) Applicants are expected to have a solid experience in handling Job related tasks
Operator Applicants are expected to have a solid experience in handling Job related tasks
Key Account Manager - Oklahoma City, OK Applicants are expected to have a solid experience in handling OK related tasks
Dispatcher Warehouse Applicants are expected to have a solid experience in handling Job related tasks