Job: Senior Regulatory Affairs Specialist
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Jobing Description
AlloSource is a non-profit organization founded in 1994 on a promise: to honor and respect the gift of donation by responsibly developing, processing and distributing life-saving and life-enhancing allografts for its communities. We deliver on this promise 24/7/365 with safe, effective and innovative allografts.
We strive to be the tissue network patients and the world's most respected transplant teams ask for by name. This is accomplished not only by offering more than 200 standard and customized precision allograft products, but also by being trusted, valued, knowledgeable partners to the medical community as well as to patients and donor families.
We are inspired every day by the patients we help and the donors we honor.
If you are looking for a challenging, fulfilling and rewarding career at a highly regarded, growing medical organization, AlloSource offers exceptional career opportunities with competitive compensation and outstanding benefits. In fact, AlloSource was chosen by the Society for Human Resources Management as one of the Best Companies to Work for in Colorado in 2007 and 2008.
As one of Americas leading non-profit tissue networks, and one of the worlds largest suppliers of fresh cartilage allografts and skin used for life-saving burn applications, AlloSource is the one organization where employees find a truly energized corporate culture, a commitment to enhancing lives, and a compelling career with advancement opportunities.
AlloSource is currently seeking a Senior Regulatory Affairs Specialist to join our outstanding team.
Position Summary:
Provide domestic and international regulatory guidance, positions and opinions needed to meet compliance to applicable regulations and standards for new product development, new markets, marketing material and regulatory submissions. This position also provides guidance and advice to AlloSource customers and AlloSource personnel.
Essential Duties And Responsibilities:
* Provide international regulatory support for product registrations.
* Support new product development initiatives/projects.
* Provide review and approval of product and process changes to ensure compliance with regulatory requirements.
* Develop, implement, and maintain procedures in support of regulatory compliance, project and/or product/process improvements.
* Review and approval of product labels, inserts and other labeling including marketing collateral to assure adequate information, instruction, cautions and warnings are present and that all labeling is in conformance to regulatory requirements and pre-market clearances, as applicable.
* Participate in internal audits as required. Assist with customer and regulatory audits as required.
* Assist with Quality System projects, Corrective and Preventive Actions, Nonconformance investigations, complaints and adverse events/reactions reports/investigations or other failure investigations.
Skills / Requirements
Education/ Formal Training Required:
* Bachelor‚s degree
Education/ Formal Training Required:
* Bachelor‚s degree in a scientific or technical field.
* Regulatory Affairs Certification (RAC).
Job and Industry Experience Required:
* A minimum of 5 years‚ experience in an FDA regulated industry (ex. Tissue banking, medical device, biologics or pharmaceutical)
* Two years direct experience with International regulatory affairs (medical device/pharma/biologics).
* Minimum of three years of FDA related regulatory/quality experience.
* Previous experience in a position that required multi-departmental interactions.
Job and Industry Experience Preferred:
* Preferred experience shall include direct experience with all aspects of Regulatory Affairs and Quality Assurance Systems, and indirect experience with business development, marketing, research & development, sales and operations/manufacturing.
Important Notes
If you are seeking a challenging career opportunity in a growing organization, click on the "APPLY HERE" link listed below. This will direct you to the job posting on the AlloSource career site.
Reference that you found this fantastic career opportunity on the Jobing.com network of employment websites.
NOTE: For consideration you must submit a resume by position close date and meet minimum requirements. All offers are contingent upon a background check and drug screen. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-4763.
AlloSource offers equal opportunity employment to all qualified employees and applicants for employment without regard to race, creed, color, sex, national origin, age, disability or veteran status. Most of our employment opportunities are posted internally for employees consideration. AA EOE
