What are the responsibilities and job description for the Regulatory Affairs Specialist position at MedSource Labs?
Job Description
At MedSource Labs, we are committed to improving patient outcomes and providing our customers with high-quality products at cost-effective prices. We are a manufacturer of medical products that are sold throughout the world. We are seeking a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist is responsible for the creation, implementation, and management of the Quality System and performing the day-to-day tasks associated with the regulatory aspects of the business and our products.
Responsibilities:
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.
We hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our company stronger. We value our employees; and embrace their qualities and the experiences they bring with them.
Company Description
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.
At MedSource Labs, we are committed to improving patient outcomes and providing our customers with high-quality products at cost-effective prices. We are a manufacturer of medical products that are sold throughout the world. We are seeking a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist is responsible for the creation, implementation, and management of the Quality System and performing the day-to-day tasks associated with the regulatory aspects of the business and our products.
Responsibilities:
- Develops and manages the Quality System.
- Educate personnel and customers about compliance regulations.
- Notifies superiors of any issues that could adversely affect the product, processes, and/or the relationship with customers.
- Responsible for completing and submitting daily and weekly reports to superiors as instructed.
- Performs responsibilities required by the QSR and other duties as assigned or requested.
- Communicate with regulatory agencies
- Identify relevant and updated guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents, this will include the MSL electronic library of standards.
- Determine and advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Compile and maintain regulatory documentation databases or systems.
- Participate in internal and external audits.
- Lead the preparation, review, and approval of risk management files.
- Experience with and knowledge of FDA medical device classifications, regulatory requirements, and submissions.
- Experience with and knowledge of quality management systems, patient safety and risk management, and health information technology.
- Familiarity with FDA 21 CFR 820, ISO 13485, ISO 14971, and other domestic and international regulations and standards.
- Excellent written and oral communication skills.
- Strong analytical and critical thinking skills.
- Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
- Prioritize tasks.
- Proven experience monitoring policies, procedures, and standards.
- Ability to work with team members to resolve problems and achieve goals.
- Experience recommending change.
- Be able to problem-solve different types of quality challenges.
- A Bachelor of Science degree in engineering, the sciences, or a related discipline preferred.
- ISO 13485 Internal auditor certification preferred.
- ISO 14971 Risk Management certification preferred.
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.
We hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our company stronger. We value our employees; and embrace their qualities and the experiences they bring with them.
Company Description
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.
MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. By delivering top-quality products and solutions at cost-effective prices, MedSource Labs has been helping improve patient outcomes since 2002. The privately held company, headquartered in Chanhassen, Minnesota, serves health care professionals including emergency medical providers, hospitals and surgical centers, veterinarian and dental providers, and government agencies.