Compliance Advisory Executive Director at SMBC Nikko Securities managing Advisory Compliance for Securitized Products Group with a focus on regulatory and compliance matters.
About the role
- Regulatory Affairs Specialists at Arthrex responsible for managing regulatory approval for medical devices. Join a global medical device company focused on innovative education and development.
Responsibilities
- Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status
- May evaluate the risk of proposed regulatory strategies and offer solutions as applicable
- Advise project teams on premarket regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues
- Provide project teams with on-going support to resolve any real or perceived regulatory issues
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
- Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines
- Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions
- Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
- Review and approve design control documentation, engineering change requests, manufacturing and labeling changes, and other applicable requests for adherence to global regulatory compliance
- Review and approve product advertising/promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies
- Review or edit regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability
- Communicate with regulatory agencies with or without direction regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies
- Establish, develop and maintain positive relationships with regulatory agency personnel
- Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products
- Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents
- Explain regulations, guidances, policies, and/or procedures to stakeholders, as applicable
- Review clinical protocols to ensure collection of data is sufficient for regulatory submissions
- Recommend changes to company procedures in response to changes in regulations, guidances and/or standards
- Obtain and distribute updated information regarding domestic or international laws, guidances and/or standards
- Write or update standard operating procedures, work instructions, or policies
- Participate in internal or external audits, as required
- May develop or conduct employee regulatory training
Requirements
- Bachelor's degree required
- RA Specialist I - Experience in a regulatory industry preferred
- RA Specialist II - 2 years regulatory experience required, preferably in medical device industry
- RA Specialist Senior - 5 years relevant experience required in a highly regulated industry
- Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
- Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence
- Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making
- Ability to comprehend principles of engineering, physiology and medical device use
- Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents
- Ability to review, collate, describe and summarize scientific and technical data
- Ability to organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures
- Ability to build strong relationships both internally and externally
- Ability to work in a fast paced environment
Benefits
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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