Regulatory Compliance Senior
POSITION PROFILEThe Regulatory Compliance Sr.
Manager is responsible for building and leading Ricoh's regulatory compliance program, policies and practices to ensure that Ricoh complies with FDA standards.
Establishing best practices to support compliance.
Communicating compliance information to senior leadership.
Ensures the organization complies with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Health Insurance Portability and Accountability Act (HIPAA), and accreditation standards (FDA 21 CFR 820, ISO 13485, MDSAP/Health Canada, MDR 2017-745/EU) and acts as a consultative resource and functions as the key company representative to the FDA for regulatory issues.
JOB DUTIES AND RESPONSIBILITIESResponsible to build regulatory compliance program including all policies and practices to ensure Ricoh's compliance with FDA standards.
Advises and makes recommendations to senior leaders about all regulatory compliance issues.
Serves as primary resource for compliance and regulatory matters with applicable federal and state rules and regulations.
Acts as a consultative resource for all regulatory compliance matters.
Provides education and training about actual, proposed, or pending legislation and regulations that impacts the business and identifying obstacles to compliance, and working with others to identify and implement solutions.
Perform assessment of healthcare compliance policy and procedure and assist in updating or developing new policies to enhance operations or/and internal controls or to consider new areas.
Review test strategies to comply to regulatory requirements for verification and validation of medical device products to support marketing application.
Manage and direct healthcare training and educational programsSupervise compliance training in other laws such as the Federal Food, Drug and Cosmetic Act, Physician Payment Sunshine Act, HIPAA, and related state laws to inform employees on ethical and legal standards.
Leverage familiarity and understanding with the PhRMA Code, OIG-DHHS seven elements of an effective compliance program, and the AdvaMed CodeWork closely with others in related departments, including legal, Quality, HR, IT, and Finance for effective investigation, resolution, reporting, and remediation of compliance issuesPrepare report for management on incidents, investigations, and all compliance issuesAssist HIPAA Privacy Officer in carrying out their responsibilitiesUnderstands and interprets U.
S.
and international medical device regulatory requirements.
Shall support the appropriate FDA premarket and post market regulatory requirements for medical device development efforts.
Provides guidance on regulatory requirements to product development teams.
Develops strategies for submissions to FDA and other regulatory agencies.
Provide guidance to product teams in the conduct of meetings with the FDA;Provide guidance to product teams for development of contract documents and statement of works for the development of medical devices.
Provides risk assessments and compliant regulatory options to support mitigationIdentify regulatory issues that need input of other regulatory Subject Matter Experts (SMEs) and obtaining that input; provide guidance on regulatory pathway development and regulatory strategy;Prepares U.
S.
regulatory submissions necessary for new product market clearance/approval and product continuance:
510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements.
Responsible to ensure all FDA communications, both formal and informal are documented and presented within the stated requirements.
Ensure timely receipt of and provide regulatory review of all FDA communications for externally sponsored products, serve as a point-of-contact with FDA and regulatory staff of external collaborators.
Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
Provide regulatory assessment, consult, and regulatory opinion for medical devicesParticipates in the development and review of product release documents.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.
Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.
Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirementsAssists in the tracking/reporting of Ricoh medical device products; responsible for timely execution of required registration/listing or other Annual Reporting activity.
QUALIFICATIONS (Education, Experience, and Certifications)10
years' experience leading regulatory affairs activity (pre- market and post-market) for a medical device company (class II or class III) MS with RAC certification or PhD preferredPrevious experience working for the FDA preferred.
Strong ability to prioritize and perform multiple projects concurrentlyStrong communication skills to effectively report project risks and progress to senior management and colleagueStrong knowledge of Microsoft Office applicationsProven ability to collaborate and advice management on compliance matters; ability to develop practical business solutions and to facilitate risk assessmentExperience applying FDA Title 21 CFR for regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA compliance, and regulations and guidelines to ensure compliance to design controls for the development of devices.
Experience in medical product development.
Experience in coordination of regulatory activities within internal and external teams.
Experience in advising product development teams on regulatory issues.
Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDAExperience with additively manufactured medical devices preferred.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants, including those who may have arrest and conviction records.
At Ricoh, we embrace and respect the collective and unique talents, experiences, and perspectives of all people.
Together, we inspire remarkable innovation.
That is how we live the Ricoh Way.
And with our commitment to ethics, you can be sure that we are doing it with transparency, integrity, and corporate social responsibility.
Ricoh is an EEO/Affirmative Action Employer -- Minorities/Women/Protected Veterans/Disabled.
Salary:
$51.
28 - $84.
52.
Estimated Salary: $20 to $28 per hour based on qualifications.
Manager is responsible for building and leading Ricoh's regulatory compliance program, policies and practices to ensure that Ricoh complies with FDA standards.
Establishing best practices to support compliance.
Communicating compliance information to senior leadership.
Ensures the organization complies with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Health Insurance Portability and Accountability Act (HIPAA), and accreditation standards (FDA 21 CFR 820, ISO 13485, MDSAP/Health Canada, MDR 2017-745/EU) and acts as a consultative resource and functions as the key company representative to the FDA for regulatory issues.
JOB DUTIES AND RESPONSIBILITIESResponsible to build regulatory compliance program including all policies and practices to ensure Ricoh's compliance with FDA standards.
Advises and makes recommendations to senior leaders about all regulatory compliance issues.
Serves as primary resource for compliance and regulatory matters with applicable federal and state rules and regulations.
Acts as a consultative resource for all regulatory compliance matters.
Provides education and training about actual, proposed, or pending legislation and regulations that impacts the business and identifying obstacles to compliance, and working with others to identify and implement solutions.
Perform assessment of healthcare compliance policy and procedure and assist in updating or developing new policies to enhance operations or/and internal controls or to consider new areas.
Review test strategies to comply to regulatory requirements for verification and validation of medical device products to support marketing application.
Manage and direct healthcare training and educational programsSupervise compliance training in other laws such as the Federal Food, Drug and Cosmetic Act, Physician Payment Sunshine Act, HIPAA, and related state laws to inform employees on ethical and legal standards.
Leverage familiarity and understanding with the PhRMA Code, OIG-DHHS seven elements of an effective compliance program, and the AdvaMed CodeWork closely with others in related departments, including legal, Quality, HR, IT, and Finance for effective investigation, resolution, reporting, and remediation of compliance issuesPrepare report for management on incidents, investigations, and all compliance issuesAssist HIPAA Privacy Officer in carrying out their responsibilitiesUnderstands and interprets U.
S.
and international medical device regulatory requirements.
Shall support the appropriate FDA premarket and post market regulatory requirements for medical device development efforts.
Provides guidance on regulatory requirements to product development teams.
Develops strategies for submissions to FDA and other regulatory agencies.
Provide guidance to product teams in the conduct of meetings with the FDA;Provide guidance to product teams for development of contract documents and statement of works for the development of medical devices.
Provides risk assessments and compliant regulatory options to support mitigationIdentify regulatory issues that need input of other regulatory Subject Matter Experts (SMEs) and obtaining that input; provide guidance on regulatory pathway development and regulatory strategy;Prepares U.
S.
regulatory submissions necessary for new product market clearance/approval and product continuance:
510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements.
Responsible to ensure all FDA communications, both formal and informal are documented and presented within the stated requirements.
Ensure timely receipt of and provide regulatory review of all FDA communications for externally sponsored products, serve as a point-of-contact with FDA and regulatory staff of external collaborators.
Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
Provide regulatory assessment, consult, and regulatory opinion for medical devicesParticipates in the development and review of product release documents.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.
Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.
Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirementsAssists in the tracking/reporting of Ricoh medical device products; responsible for timely execution of required registration/listing or other Annual Reporting activity.
QUALIFICATIONS (Education, Experience, and Certifications)10
years' experience leading regulatory affairs activity (pre- market and post-market) for a medical device company (class II or class III) MS with RAC certification or PhD preferredPrevious experience working for the FDA preferred.
Strong ability to prioritize and perform multiple projects concurrentlyStrong communication skills to effectively report project risks and progress to senior management and colleagueStrong knowledge of Microsoft Office applicationsProven ability to collaborate and advice management on compliance matters; ability to develop practical business solutions and to facilitate risk assessmentExperience applying FDA Title 21 CFR for regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA compliance, and regulations and guidelines to ensure compliance to design controls for the development of devices.
Experience in medical product development.
Experience in coordination of regulatory activities within internal and external teams.
Experience in advising product development teams on regulatory issues.
Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDAExperience with additively manufactured medical devices preferred.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants, including those who may have arrest and conviction records.
At Ricoh, we embrace and respect the collective and unique talents, experiences, and perspectives of all people.
Together, we inspire remarkable innovation.
That is how we live the Ricoh Way.
And with our commitment to ethics, you can be sure that we are doing it with transparency, integrity, and corporate social responsibility.
Ricoh is an EEO/Affirmative Action Employer -- Minorities/Women/Protected Veterans/Disabled.
Salary:
$51.
28 - $84.
52.
Estimated Salary: $20 to $28 per hour based on qualifications.
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