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Benchmark · 7 hours ago

Regulatory Affairs Spec II

Rochester, MN

Full-time

Onsite

Mid, Senior Level

$80K/yr - $99K/yr

5+ years exp

Benchmark is a company driven by the purpose of innovating for a healthier, safer, and better-connected world. The Regulatory Affairs Specialist is responsible for ensuring compliance with quality management standards and governmental regulations while providing support for manufacturing and product development.

ElectronicsManufacturing

Responsibilities

Working knowledge of ISO 13485

Working knowledge of FDA QSR/QMSR (21CFR part 820)

Medical Device Experience

Auditing internal and external

Reviewing and approving of documentation

Participates and contributes to regulatory departmental management meetings and goal accomplishment

Serves as customer team liaison for customer audits/questions related to specification requirements

Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication

Monitors and report on key quality and performance indicators as related to regulatory system conformance

Keeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices

Actively participates in continuous improvement initiatives

Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements

Participates with customer teams, supporting NPI and ongoing production needs related to regulatory requirements

Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products

Capable of performing timely and accurate review of MRR and MRR waiver submittal

Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation

Demonstrate effective customer interface skills

Demonstrate confidentiality

Ability to work with supervision and guidance

Demonstrate strong and effective interpersonal skills

Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers

Demonstrate strong problem solving and decision making skills

Demonstrate strong organizational skills

Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred

5+ years of regulatory experience with moderate to complex key customers

Demonstrate the ability to interpret and communicate moderately complicated quality system regulations

Work with larger customers and more complex regulatory requirements and audits

Recommend new or revised metrics to better qualify/quantify performance

May lead continuous improvement efforts in functional or cross-functional teams

May give direction and leadership to lower level employees

Provide regulatory product support including review of change plans, CAPAs and documentation for changes requiring regulatory body approval, and post-market requirements

Lead CAPAs and support the CAPA management process through activities such as verification of effectiveness

Maintain internal audit requirements checklists, ensuring that applicable standards are utilized and updated as revisions are introduced

Conduct internal audits and support external audits and inspections

Work with cross functional teams to implement quality management system improvements

Act as a regulatory representative on product development teams and communicate regulatory requirements and impact of regulations to the development team

Qualification

ISO 13485FDA QSR/QMSRMedical Device ExperienceAuditingRegulatory ComplianceQuality Management StandardsInterpersonal SkillsCommunication SkillsProblem SolvingOrganizational Skills

Required