דרושים Regulatory Affairs Specialist ב-United States, Massachusetts, Waltham
Bank Of America Business Control Specialist - Lending United States, Massachusetts, Waltham
This job is responsible for executing on internal control discipline and operational excellence within a Line of Business (LOB) or Enterprise Control Function (ECF). Key responsibilities include providing analytical and administrative support for LOB or ECF specific processes and tools to drive adherence to enterprise-wide standards. Job expectations include supporting the implementation of quality assurance and quality control processes within the LOB or ECF by gathering and organizing data to help identify, track, and report issues and control improvements for remediation.
Responsibilities:
Proficient in identifying data entry from a variety of sources, paper-based and/or electronic, into the loan system of record
Should have experience in account setup and loan servicing. Commercial/wholesale lending preferred
Have a general knowledge of loan structure, loan agreements and credit regulations
Identify and escalate quality assurance findings promptly, following appropriate communication channels
Communication - clear and concise communication of quality assurance findings
Drive execution - ownership and prompt follow up on defect remediation; debate of disputes in a professional manner and in accordance with process and procedures
Drive Change - support project work across multiple teams/sites. Influence change by identifying process gaps and recommending appropriate solutions – in compliance with current laws and regulations
Technology – commitment to technology initiatives and improvements
Proficient computer skills utilizing mainframe and PC software packages; Working knowledge of Microsoft Excel, Word, Power-Point with dual screens
Capability to work with multiple systems in order to validate accuracy
Collaborates – works effectively with others by establishing and maintaining positive working relationships
Act in accordance with the letter and spirit of all applicable laws, rules and regulations, the company’s code of conduct, risk framework, risk appetite statement and other relevant policies, standards, procedures and guidance. Is proactive in identifying, managing and controlling risks within the fulfillment space
Assesses the design and effectiveness of the risk and control environment to support Client Operational Services and ensure adherence to enterprise-wide standards
Provides administrative support for the monitoring and testing of controls by gathering and organizing data to identify issues and control improvements for remediation
Complies with controls and Quality Assurance (QA) practices to support business continuity efforts
Conducts and coordinates quality inspection reviews to enhance employee performance and control effectiveness
Performs QA activities including executing on controls, managing cases, and reporting results
Supports initiatives by identifying potential procedural updates, test script updates, and data discrepancies to enhance QA program success
Supports operational research required for regulatory exams, internal audits, and other monitoring and inspection reviews and captures data and information relevant to inspection metrics to support governance activities for dashboard reporting
Required Skills:
Minimum of 2 years of experience in the field of loan or accountadministrator/processoror equivalent (Commercial /wholesale lending preferred.
Effective communication skills (listening, verbal and written)
Working knowledge of Microsoft Excel, Word, Power-Point with dual screens
Desired Skills:
Strives to bring new thoughts and ideas to teams in order to drive innovation and unique solutions.
Excels in working among diverse viewpoints to determine the best path forward.
Experience in connecting with a diverse set of clients to understand future business needs – is a continuous learner.
Commitment to challenging the status quo and promoting positive change.
Participate in and drive collaborative efforts to advance tools, technology, and ways of working to better serve an evolving client base.
Believes in value of diversity so we can reflect, connect and meet the diverse needs of our clients and employees around the world.
Skills:
Controls Management
Issue Management
Monitoring, Surveillance, and Testing
Quality Assurance
Risk Management
Analytical Thinking
Attention to Detail
Critical Thinking
Problem Solving
Written Communications
Decision Making
Innovative Thinking
Prioritization
Recording/Organizing Information
משרות נוספות שיכולות לעניין אותך
Boston Scientific Principal Regulatory Affairs Specialist United States, Massachusetts, Waltham
This is a hybrid role (in office 3 days per week) based in Waltham, Massachusetts or Arden Hills, Minnesota.Your responsibilities will include:
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
- Represents Regulatory Affairs on cross functional projects which may include new product development, design/manufacturing changes, and continuous improvement efforts
- Develops regulatory strategies for Class II and III electronic medical equipment devices
- Coordinates, compiles, and submits US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
- Supports international regulatory partners with investigational device and commercial marketing applications
- Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Technical and labeling reviews of supporting documents for inclusion in regulatory filings
- Develops and maintains positive relationships with regulatory agency staff
- Lead and/or participate in regulatory audits, as required
Required Qualifications:
- Minimum of a Bachelor's Degree
- Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
- Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
- Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
- Strong technical, research and problem-solving skills
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred Qualifications:
- Experience working directly with FDA, notified bodies and/or international health authorities
- Prior experience with electrophysiology and/or capital equipment/software devices
- Able to work independently with minimal supervision
- Demonstrated leadership, strategic thinking, project planning, and project management skills
- Able to work well in fast-paced cross-functional team environments
- Ability to articulate complex ideas clearly both verbally and in writing
- Demonstrated ability to develop strong relationships with regulatory agency staff
- Demonstrated ability to effectively lead multiple regulatory projects and priorities
- Prior experience providing technical guidance, training, and/or mentoring to Regulatory Affairs and/or cross-functional peers
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
משרות נוספות שיכולות לעניין אותך
This job is responsible for executing on internal control discipline and operational excellence within a Line of Business (LOB) or Enterprise Control Function (ECF). Key responsibilities include providing analytical and administrative support for LOB or ECF specific processes and tools to drive adherence to enterprise-wide standards. Job expectations include supporting the implementation of quality assurance and quality control processes within the LOB or ECF by gathering and organizing data to help identify, track, and report issues and control improvements for remediation.
Responsibilities:
Proficient in identifying data entry from a variety of sources, paper-based and/or electronic, into the loan system of record
Should have experience in account setup and loan servicing. Commercial/wholesale lending preferred
Have a general knowledge of loan structure, loan agreements and credit regulations
Identify and escalate quality assurance findings promptly, following appropriate communication channels
Communication - clear and concise communication of quality assurance findings
Drive execution - ownership and prompt follow up on defect remediation; debate of disputes in a professional manner and in accordance with process and procedures
Drive Change - support project work across multiple teams/sites. Influence change by identifying process gaps and recommending appropriate solutions – in compliance with current laws and regulations
Technology – commitment to technology initiatives and improvements
Proficient computer skills utilizing mainframe and PC software packages; Working knowledge of Microsoft Excel, Word, Power-Point with dual screens
Capability to work with multiple systems in order to validate accuracy
Collaborates – works effectively with others by establishing and maintaining positive working relationships
Act in accordance with the letter and spirit of all applicable laws, rules and regulations, the company’s code of conduct, risk framework, risk appetite statement and other relevant policies, standards, procedures and guidance. Is proactive in identifying, managing and controlling risks within the fulfillment space
Assesses the design and effectiveness of the risk and control environment to support Client Operational Services and ensure adherence to enterprise-wide standards
Provides administrative support for the monitoring and testing of controls by gathering and organizing data to identify issues and control improvements for remediation
Complies with controls and Quality Assurance (QA) practices to support business continuity efforts
Conducts and coordinates quality inspection reviews to enhance employee performance and control effectiveness
Performs QA activities including executing on controls, managing cases, and reporting results
Supports initiatives by identifying potential procedural updates, test script updates, and data discrepancies to enhance QA program success
Supports operational research required for regulatory exams, internal audits, and other monitoring and inspection reviews and captures data and information relevant to inspection metrics to support governance activities for dashboard reporting
Required Skills:
Minimum of 2 years of experience in the field of loan or accountadministrator/processoror equivalent (Commercial /wholesale lending preferred.
Effective communication skills (listening, verbal and written)
Working knowledge of Microsoft Excel, Word, Power-Point with dual screens
Desired Skills:
Strives to bring new thoughts and ideas to teams in order to drive innovation and unique solutions.
Excels in working among diverse viewpoints to determine the best path forward.
Experience in connecting with a diverse set of clients to understand future business needs – is a continuous learner.
Commitment to challenging the status quo and promoting positive change.
Participate in and drive collaborative efforts to advance tools, technology, and ways of working to better serve an evolving client base.
Believes in value of diversity so we can reflect, connect and meet the diverse needs of our clients and employees around the world.
Skills:
Controls Management
Issue Management
Monitoring, Surveillance, and Testing
Quality Assurance
Risk Management
Analytical Thinking
Attention to Detail
Critical Thinking
Problem Solving
Written Communications
Decision Making
Innovative Thinking
Prioritization
Recording/Organizing Information
משרות נוספות שיכולות לעניין אותך
