Regulatory Affairs Specialist 1
Job CountryUnited States
CategoryRegulatory & Quality
Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics. Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.
With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Orthos high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.
Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadnt thought possible before.
Orthos purpose is simple: to improve and save lives with diagnostics. They do that by reimagining whats possible. Its what defines them. Its the Ortho difference.
Ortho is an independent company, sponsored by The Carlyle Group, one of the worlds largest and most successful investment firms. The companys executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. Thats something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. Its who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
As the company continues to grow, we are seeking a
Regulatory Affairs Specialist - Transfusion Medicine
in Raritan, NJ.
The Regulatory Specialist will be responsible for assisting in the coordination, compilation and submission of post-market regulatory applications to the U.S. Federal Food & Drug Administration (FDA) and will support day to day Transfusion Medicine Regulatory Operations. The ideal candidate will exhibit the aptitude for developing the ability to interpret regulatory requirements and strategies to obtain licensure of BLA and clearance of 510(k) products under the direction of Regulatory Management.
S/he will represent Regulatory Affairs in project meetings and interact with Ortho management to expedite pending state and federal license and registration renewals, resolve regulatory matters and coordinate development meetings for regulatory submissions and work on projects/matters of limited complexity in a support role regarding work processes or operational plans and schedules.
The Regulatory Specialist will work with team members and business partners to oversee the regulatory aspects of post market submission of license applications and assessment of the impact that product changes may have on the status of regulatory approvals/clearances.
On occasion, this position may require the participation on New Product Development teams to provide regulatory assistance, under management supervision, to obtain rapid and timely approval of new products. This individual will be responsible for leading Regulatory based projects and/or initiatives to support departmental goals and objectives.
- Under the direction of Regulatory management, provide support to Regulatory staff in the submission of post-market regulatory supplements for IVD licensed biologics and new 510(k) devices.
- Routine responsibilities include providing Regulatory operational support for currently marketed products, which includes the review of product/process related Change Controls, Design History Files and renewal of state and federal licenses.
- Additional roles of this position includes the support of regulatory compliance responsibilities to existing U.S. FDA regulations as they pertain to Annual Report filing for maintenance of product licensure and database management of Biological Product Deviation Reports for the portfolio of BLA products.
- Maintenance of Global Unique Device Identification Database (GUDID).
- The candidate will ensure timely reporting as applicable to described duties.
- S/he will also maintain collaborative relationships with Product Support, R & D, Operations, Product Labeling, Quality partners and the International Regulatory Affairs group.
- As needed, when determined appropriate by Regulatory Management, the candidate may be asked to work with external business partners.
- Provide audit support during regulatory inspections, both domestic and international.
- The Regulatory Specialist will also lead and/or provide support to departmental initiatives, such as process improvement and streamlining.
- A Bachelors Degree in a scientific discipline is required.
- 0-2 years experience. Experience in an FDA regulated environment is a plus.
- Experience preparing documentation in support of Regulatory and/or legal functions is a plus.
- Ability to think analytically and work independently in certain situations is preferred.
- Knowledge and understanding of biological terms, concepts and processes is a plus.
- Experience working with cross-functional teams is desirable but not required.
- Candidate must have the ability to provide innovative suggestions within the boundaries of U.S. regulations, have the ability to organize data and identify issues or gaps and have the ability to effectively communicate in oral and written forms.
- Willingness to gain knowledge and experience in FDA regulations and its application to Orthos Transfusion Medicine business.
- Working knowledge of Microsoft Office Suite applications.
- This position is based in Raritan, NJ and requires up to 15% travel both domestically and internationally.
- Work visa sponsorship is not available for this position.
Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ********************************************.
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At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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