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Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.
Montgomery Village, MDToday
Highlights
As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect.
Numbers & Facts
| Location | MD |
| Industry | Other/Not Classified |
| Salary | $95,000–$125,000 Per Year |
| Company Size | 500 to 999 employees |
| Year Founded | 1974 |
| Website | http://goldbelt.com |
Description
Overview
Please note that this position is contingent upon the successful award of a contract currently under bid.
Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.
Summary:
Goldbelt APEX is looking for a Regulatory Affairs Support - WEMT.
Responsibilities
Essential Job Functions:
- Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
- Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
- Support FDA/regulatory agency interactions.
- Conduct regulatory gap analyses.
- Advise product managers and IPTs on regulatory risk and product lifecycle strategy.
Qualifications
Necessary Skills and Knowledge:
- FDA regulatory affairs.
- Medical product development lifecycle.
- Drugs, biologics and/or medical devices.
- Regulatory submissions.
- Clinical/preclinical development.
Minimum Qualifications:
- In-depth understanding of regulatory requirements throughout the medical product lifecycle.
- Strong understanding of drugs, biologics, blood/blood products, medical devices and/or related medical solutions.
- Strong analytical and problem-solving ability.
- Ability to work independently and collaboratively.
- Travel: Up to 20%
Preferred Qualifications:
- Current WEMT Regulatory Affairs incumbent.
- Direct IND/NDA/PMA/510(k) experience.
- FDA meeting/submission experience.
- DoD/DHA medical product experience.
- RAC or comparable regulatory credential.
Pay and Benefits
The annual salary for this position is $95,000 to $125,000.
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
About Company
Goldbelt, Incorporated is an urban Alaska Native, for‐profit corporation headquartered in Juneau, Alaska. Incorporated on January 4, 1974 following the Alaska Native Claims Settlement Act (ANCSA), Goldbelt’s primary mission is to manage assets and conduct business for the benefit of its more than 3,600 shareholders. Goldbelt first ventured into the logging and timber industry but later expanded its operations into tourism, which still remains an integral part of its operations. Today, the majority of Goldbelt’s revenue and income derives from government contracting and services.
Goldbelt’s shareholder base consists of Alaska Natives who are of Tlingit and Haida descent. The Tlingit and Haida tribes are the indigenous people of Southeast Alaska, whose rich history spans more than ten thousand years in the region. Goldbelt shareholders own the entire 272,000 shares of Goldbelt stock, representing assets in excess of $100 million in addition to over 32,000 acres of land in the vicinity of Juneau. Goldbelt seeks to honor and preserve the Tlingit culture - its history, art, dance, legends, and the traditions of its Alaska Native shareholders. Learn more about Goldbelt Heritage.
The company is named after a richly mineralized zone in Southeast Alaska that encompasses 33,000 acres of Goldbelt’s land holdings— an area that stretches along the mainland from Frederick Sound to Berners Bay. Learn more about Goldbelt Lands.