Manager, Regulatory Affairs
Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight. Use in-depth applied knowledge and understanding of US domestic and EU medical device regulations (including 510k, PMA submissions and supplements, EU technical documentation/dossiers) to assume regulatory responsibility for supporting new product development and sustaining engineering projects. Utilize expert base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to provide regulatory direction and guidance to project teams to ensure that the product portfolio and the required regulatory documentation is optimized for the business. Scope emerging regulatory trends that may impact the current business and apply to existing regulatory initiatives. Independently evaluate regulatory issues and perform research, as required, to develop and implement regulatory strategies for the assigned program; maintain up to date and expert knowledge of regulatory requirements and guidance, and communicate changes in regulatory information and develop proposals to address changes, as needed. Implement regulatory strategies to revise technical documentation for existing and new regulatory submissions. Manage the development of US and EU regulatory strategies and coordinate with international regulatory to determine global regulatory requirements. Author submissions (510k, PMA, EU Technical Documentation/Tech Files) independently. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Independently interact with Regulatory Body personnel. Actively lead and/or manage the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company's Notified Bodies regarding regulatory issues/questions and lead Technical Documentation/Technical File reviews. Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements. Review promotional and advertising material and provide expert guidance for adherence to approved product claims and regulatory compliance. Manage partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, and European regulations and Directives. Manage the planning and coordination of commercialization of new products and product changes based on regulatory approval status. Work with cross-functional teams to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Manage the regulatory review of complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. Review labeling to ensure compliance with US and EU regulations Problem solving:
Provide solutions to a variety of problems including those of a highly complex nature. Provide leadership and mentoring to regulatory team members by coaching about best practices of a RA professional using Integra values as a guide. Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization. Author SOPs and train key personnel as needed. Perform other duties as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 5-7 years regulatory experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma Strong experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Expert applied knowledge of domestic and/or international medical device regulations including 510(k), PMA, PMA Supplements, and international dossier submissions; Experience with medical device, combination products, or implantable products is preferred, but not required. Strong applied understanding of business strategies and tactics, including an understanding of regulatory impact. Ability to effectively interface with multiple company disciples and responds to complex questions related regulatory requirements. Must have proven ability to prepare and submit documents to regulatory agencies independently. Ability to explain regulatory requirements and challenges to project teams and colleagues. Able to effectively communicate in an organized and clear manner to cross-functional teams. Proven experience in effectively communicating and working with US FDA, European Notified Bodies, Competent Authorities, and other regulatory agencies. Must be detail oriented, well-organized, and able to work both independently and in teams. Must possess and demonstrate a deep understanding of FDA requirements for medical devices, European Medical Device Directive (MDD) and Medical Device Regulations (MDR). Proven skills in the planning, management, and approval of CE registrations and US 510(k) Premarket Notifications or Premarket Approvals (PMAs and Supplements). Must have strong data analysis, technical writing, project management and communication skills. Demonstrated skills handling multiple demanding projects and in contributing to multiple projects simultaneously. Established skill in objective and critical thinking. Develops proposals for solutions and applies solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and advanced submission components with ability to create templates when non exist. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Ability to communicate effectively in both informal and formal settings.
Salary Range:
$100K -- $150K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
Provide solutions to a variety of problems including those of a highly complex nature. Provide leadership and mentoring to regulatory team members by coaching about best practices of a RA professional using Integra values as a guide. Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization. Author SOPs and train key personnel as needed. Perform other duties as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 5-7 years regulatory experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma Strong experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Expert applied knowledge of domestic and/or international medical device regulations including 510(k), PMA, PMA Supplements, and international dossier submissions; Experience with medical device, combination products, or implantable products is preferred, but not required. Strong applied understanding of business strategies and tactics, including an understanding of regulatory impact. Ability to effectively interface with multiple company disciples and responds to complex questions related regulatory requirements. Must have proven ability to prepare and submit documents to regulatory agencies independently. Ability to explain regulatory requirements and challenges to project teams and colleagues. Able to effectively communicate in an organized and clear manner to cross-functional teams. Proven experience in effectively communicating and working with US FDA, European Notified Bodies, Competent Authorities, and other regulatory agencies. Must be detail oriented, well-organized, and able to work both independently and in teams. Must possess and demonstrate a deep understanding of FDA requirements for medical devices, European Medical Device Directive (MDD) and Medical Device Regulations (MDR). Proven skills in the planning, management, and approval of CE registrations and US 510(k) Premarket Notifications or Premarket Approvals (PMAs and Supplements). Must have strong data analysis, technical writing, project management and communication skills. Demonstrated skills handling multiple demanding projects and in contributing to multiple projects simultaneously. Established skill in objective and critical thinking. Develops proposals for solutions and applies solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and advanced submission components with ability to create templates when non exist. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Ability to communicate effectively in both informal and formal settings.
Salary Range:
$100K -- $150K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
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