Regulatory Affairs Specialist II

Summary Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development. 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 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 reports 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 Qualifications & Other Information 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 4 year College Degree or equivalent combination of education and experience as approved by executive management 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. Education 4 year College Degree or equivalent combination of education and experience as approved by executive management 5+ years of regulatory experience with moderate to complex key customers Location Geographical Location: Minnesota: Winona Physical Location: Winona, MN - Central (4155) Shift & Schedule Shift: Shift 1 Work Schedule: M-F 0800-1700 Full Time Compensation Range $81,154.00 to $99,453.00 USD. Benefits Benchmark provides a comprehensive benefits package, including a Bonus Plan, 401(k), Paid Time Off, and Health, Dental, and Vision Insurance, all based on scheduled hours. Benchmark complies with applicable state and local employee leave laws. Application Deadline This job posting will remain open until filled. Export Control This job position may include access to controlled information or technology covered under applicable U.S. export control laws. As such, employment for this job position may be contingent on either verification that an applicant falls under the definition of a “U.S. Person” or on the Company timely obtaining any necessary export license required under federal laws. The Company evaluates such export license situations on a case‑by‑case basis and may decline to proceed with a job applicant in its sole discretion since export license applications can take many weeks to be processed. Equal Opportunity Employment Benchmark is an equal opportunity employer. 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