J&J Family of Companies
Senior Regulatory Affairs Specialist
Columbia ,
South Carolina
Apply Now
Senior Regulatory Affairs Specialist - 2406193618W
Description
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist.
Remote work options may be considered on a case-by-case basis and if approved by the Company
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period. Your core focus will be regulatory support for software (both SiMD and SaMD) and hardware development and changes. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
The ideal candidate will:
Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions that include software and hardware components
Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
Be energized by joining a world-class company and regulatory team
Enjoy teamwork and thrive as a member of dynamic cross-functional teams
Build and maintain strong interpersonal relationships within and outside of the company
Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results
Be adaptable and thrive in a dynamic work environment where variety is the routine.
Embrace change, continuous learning, and work skills improvement
Key Responsibilities:
Support cross-functional new product development projects with a specific focus on software (both SiMD and SaMD) and hardware aspects, and lead compilation of all materials required for submissions to FDA
Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations
Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance
Provide support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings
Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions
Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies
Assist in the maintenance and improvement of regulatory SOPs
Interact and negotiate with regulatory agencies on defined matters as needed
Qualifications
Education
Bachelor's Degree in engineering or science required
Advanced degree is preferred
Required
Minimum of 4 years Regulatory Affairs experience with a Bachelor's degree or minimum of 3 years Regulatory Affairs experience with an advanced degree
History IDE/PMA/510(k) device submissions that include hardware and software components (Class III device submissions preferred)
Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions
Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance
Ability to effectively manage multiple projects and priorities
Strong communication and regulatory writing skills
Strong problem solving skills, interpersonal skills and effective team member
Results oriented. Ability to drive to completion in adherence to aggressive project schedules
Preferred
Ability to comprehend principles of engineering, physiology and medical device use.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
Other
Travel up to 10%
Must be able to effectively work remotely
This job posting is anticipated to close on 7.4.2024. The Company may however extend this time-period, in which case the posting will remain available on *** to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. The Company maintains highly competitive, performance-based compensation programs. Additional information can be found through the link below. For additional general information on company benefits, please go to: ***/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
•
United States - SC - SC - Columbia
July 1, 2024
We are seeking a locum physician (MD/DO) with a focus on neurosurgery. • Our ideal candidate must have an active state license and be board certified. • The position will involve weekend call duties at a level 1 trauma center, so comfort in a busy trauma setting is required. • Both spinal and...
United States - SC - SC - Columbia
July 1, 2024
Interested in a career in the Medical Assisting field? My Medical Career can help! START TRAINING FOR YOUR NEW MEDICAL CAREER TODAY! Graduate employment services may be available once training is complete. • This posting is for Career Training Services, provided by our network of schools located...
United States - SC - SC - Charleston
July 1, 2024
Magnet Medical is seeking a travel nurse RN Med Surg for a travel nursing job in Charleston, South Carolina. & Requirements • Specialty: Med Surg • Discipline: RN • Start Date: 07/29/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, nights • Employment Type: Travel Magnet Medical Job...
United States - SC - SC - Columbia
July 1, 2024
Speech and Hearing Therapist II Pay rate : $42.76 hr Job Location:Columbia, SC Shifts for Schools: Elementary: 7:15am - 2:15pm, Middle: 8:35 - 3:45pm, High: 8:00 - 3:15pm GENERAL STATEMENT OF JOB Under limited supervision, provides professional services to screen, identify, evaluate, treat and...
United States - SC - SC - Columbia
July 1, 2024
We are seeking an BC/BE family medicine or urgent care physician to join our team at a high volume level III trauma facility in a beautiful riverside city, with access to outdoor activities and nationally renowned beaches. • As a member of our team, you will enjoy a flexible work schedule,...
United States - SC - SC - south carolina
July 1, 2024
Overview: • Join Our Team as a CNADo you value the time you spend with your patients? Is it important to you that your patients and their families know and feel that you are with them? We are looking for certified nursing assistants who are committed to creating meaningful patient experiences....
United States - SC - SC - Beaufort
July 1, 2024
Maxim Healthcare Services is seeking a Registered Nurse (RN) to assume responsibility and accountability for the application of the nursing process and the delivery of patient care. • The Registered Nurse (RN) demonstrates the ability to make clinical judgments in an effective and efficient manner...
United States - SC - SC - Gaffney
July 1, 2024
Become a part of our caring community and help us put health first The Medical Social Worker participates in the interdisciplinary care provided to home health patients. • The Medical Social Worker functions to evaluate and develop a plan of care personalized to fit the patient's emotional and...
United States - SC - SC - Johnston
July 1, 2024
• We are currently seeking an experienced Claims Adjuster proficient in managing intricate property and casualty insurance claims. • In this pivotal role as an individual contributor, you will handle complex claims, ensuring adherence to high standards of quality, accuracy, and timely processing. •...
United States - SC - SC - West Columbia
July 1, 2024
Programmer is a technical position that supports the development and maintenance of RCMS applications and solutions. The primary purpose of this position is to support the organizational goals of the RCMS by efficiently and effectively fulfilling the responsibilities of a Programmer. • Programmer...
United States - SC - SC - West Columbia
July 1, 2024
J&J Family of Companies • Senior Regulatory Affairs Specialist • Columbia , • South Carolina • Apply Now • Senior Regulatory Affairs Specialist - 2406193618W • Description • Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. • Remote work options...
United States - SC - SC - Myrtle Beach
July 1, 2024
Overview: To provide excellent guest service through meat and seafood department activities. To use selling skills and merchandising programs to enhance guest interaction and achieve maximum sales. Responsibilities: 1. Provides polite, friendly greetings and interactions with all guests as they...
United States - SC - SC - West Columbia
July 1, 2024
Inspire health. Serve with compassion. Be the difference. • Job Summary • This job, under the direction of a radiologist or physician performs peripheral and neurological diagnostic and therapeutic radiographic and fluoroscopic procedures at a level not requiring constant supervision of technical...
United States - SC - SC - Rock Hill
July 1, 2024
Purpose: • To provide consistent and continuous assistance and care to residents and to assist licensed nursing staff with treatments and care of residents as ordered or needed. • Essential Job Functions and Requirements: • Employee work shifts as scheduled. Willing to work other variable hours when...
United States - SC - SC - Batesburg-Leesville
July 1, 2024
The Reliability Engineer is an integral part of our maintenance team focused on predictive and preventive measures for the mill. Our employees operate in a culture that values safety first and rewards hard work. We recognize and support our team culture and focus on growing our team by promoting...
United States - SC - SC - Simpsonville
July 1, 2024
Job Summary We are seeking an experienced Restaurant Manager to join our team! As the Restaurant Manager, you will be responsible for the restaurant's operational performance and financial well-being. You will hire, train, and lead staff, ensuring they reflect the restaurant's high standards. The...
United States - SC - SC - Spartanburg
July 1, 2024
Specialty/Competency: • SAP • Industry/Sector: • Not Applicable • Time Type: • Full time • Travel Requirements: • Up to 60% • A career in our SAP Human Capital practice, within SAP Consulting services, will provide you with the opportunity to help our clients maximise the value of their SAP...
United States - SC - SC - Chapin
July 1, 2024
POSITION TITLE: ASSOCIATE / CASHIER DEPARTMENT: EXPRESS LANE / PITT STOP CONVENIENCE STORES SC REPORTS TO: GENERAL MANAGER FLSA: NON-EXEMPT / HOURLY POSITION SUMMARY: • The Cashier/Associate will process customers of retail store/station in a manner that enhances the business and maintaining the...
United States - SC - SC - Fort Mill
July 1, 2024
Hey there! Do you love fashion, clothing, and shopping? Do you like the idea of sustainable and recycled styles? Kid to Kid is not your typical thrift or consignment store. We serve the community by paying cash for gently used kids' items (clothes, shoes, toys, equipment, etc) and reselling them at...
United States - SC - SC - North Charleston
July 1, 2024
TRS Healthcare is seeking a travel CT Technologist for a travel job in North Charleston, South Carolina. & Requirements • Specialty: CT Technologist • Discipline: Allied Health Professional • Start Date: ASAP • Duration: 26 weeks • 36 hours per week • Shift: 12 hours, nights • Employment Type:...
Affordable Dentures and Implants
United States - SC - SC - Spartanburg
July 1, 2024
Overview Come join our team as a Dental Assistant! This position is more than just a job, it is an opportunity to do what YOU love and get paid to do it! You will enjoy a fulfilling career like no other and will play a vital role in changing the lives of our patients. Together with our experienced...
United States - SC - SC - North Charleston
July 1, 2024
We are seeking a temporary Vascular Surgeon to join our team for a flexible assignment. • Board certification is required, and a current ACLS and BLS certification is necessary. • The role involves an average of 8-10 patients per shift and includes procedures such as aneurysm repairs, thoracic,...
United States - SC - SC - Mt Pleasant
July 1, 2024
We are actively looking to hire a talented and experienced Psychiatric Nurse Practitioner in the area who is passionate about patient care and committed to clinical excellence. Is This You? • Wanting to deliver high quality behavioral healthcare. • Seeking work/life balance. • Interested in growing...
United States - SC - SC - Orangeburg
July 1, 2024
Job Posting • As one of the largest national gasoline and convenience retailers with more than 1,650 stores in 27 states, we know that without our committed team, we are simply another retailer. Ready to be empowered to grow? We're ready for you! Hiring immediately for full-time and part-time...
United States - SC - SC - Kershaw
July 1, 2024
Salary: $14.06 Hourly • Location : Kershaw County, SC • Job Type: Temporary - Part-Time • Job Number: Temporary/166521 • Agency: SCDPH-PH Region-Midlands • Opening Date: 07/02/2024 • Closing Date: 8/2/2024 11:59 PM Eastern • Class Code:: GA33 • Slot Number:: 0000 • Position Number:: Temporary-Hourly...
United States - SC - SC - Fountain Inn
July 1, 2024
Position Overview: • Are you outgoing and customer-focused? Do you enjoy working with the public? If you answered yes to these questions, working for a State Farm independent contractor agent may be the career for you! State Farm agents market only State Farm insurance and financial service...
United States - SC - SC - Charleston
July 1, 2024
Are you a qualified Physician with a specialization in Vascular Surgery? We have an exciting opportunity for a locum Vascular Surgeon, offering the chance to work in a fast-paced environment with a strong support network. • Active state license required • Board certification (BC) required • On-call...