Sr. Regulatory Specialist/Quality Control Analyst
at HealthCare Recruiters International

Date Posted: 1/9/2019

Job Description

Sr. Regulatory Specialist/Quality Control Analyst Function: QUALITY ASSURANCE Location: Andover, MN, US, 55304 Travel: Less than 10% Job Overview Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They review, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met. Responsibilities Qualifications Responsibilities

• Manages the Regulatory Affairs function

• Develops global regulatory strategies

• Ensure compliance to 231 CFR 820, ISO 13485, MDD/MDR, MDSAP, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.

• Acts as a liaison with Quality, RD, Legal, and Operations.

• Provides regulatory guidance

• Responsible for submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.

• Prepares submissions for device design changes and /or manufacturing changes.

• Reviews product and manufacturing changes for compliance with applicable regulations

• Reviews protocols and reports to support regulatory compliance and submissions.

• Reviews device labeling and advertising materials for compliance with applicable regulations.

• Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body). Qualifications

• Bachelors degree (BS, BA) (technical discipline preferred)

• At least 3- 5 years' Regulatory experience.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Ability to travel approximately 10%, including international Competencies

• Building Effective Teams

• Managing and Measuring Work

• Motivating Others

• Values: Integrity, Accountability, Teamwork, Innovation

• SET: Strategy, Execution, Talent (for managers) Nearest Major Market: Minneapolis Job Segment: Regulatory Affairs, Law, Engineer, Lean Six Sigma, Compliance, Legal, Engineering, Management

Job Snapshot

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