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Medical Instrument Development Laboratories, Inc. · 8 hours ago

Regulatory & Quality Specialist (Senior Level Considered)

San Leandro, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $130K/yr

3+ years exp

Medical Instrument Development Laboratories, Inc. is seeking a Regulatory and Quality Specialist who will collaborate with various teams to register and maintain medical devices in global markets. The role involves leading regulatory activities, ensuring compliance with regulations, and supporting product launches throughout the product lifecycle.

Health CareHealth DiagnosticsMedical

No H1B

Responsibilities

Lead and support US and OUS product registration activities, along with developing regulatory strategy to achieve timely approvals and support business growth

Collect and analyze regulatory information/intelligence to assess changes in the regulatory landscape to ensure compliance with ISO, regulatory requirements, and the quality management system

Lead and support change impact assessments and initiate a change notification plan to external parties (Customers, Notified Body, and Regulatory Agencies) to ensure products meet all regulatory, customer, and company requirements

Work closely with R&D through the development of a regulatory strategy and objective to ensure adequate planning to bring new products to the market, as well as product sustainability and product end of life activities

Serve as a primary point of contact for global affiliates, customers, importers, and distributors of MID Labs marketed devices and OEM devices regarding registration activities

Obtain document notarization, capitalization, legalization, as needed

Identify regulatory risks for pre- and post-product launch and collaborate with stakeholders to develop effective mitigation strategies

Collaborate with R&D, Manufacturing, Marketing, and external consultants to support risk management, clinical evaluation, and labeling activities

Assist with environmental regulations and standards (i.e. RoHS, WEEE Directive, REACH, etc.)

Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation

Author and lead regulatory documentation and submissions for U.S FDA 510(k), EU MDR Technical File/Documentation, internal Letters to File, registrations/licenses, and amendments, with minimal supervision

Collect, analyze, and trend post-market surveillance data throughout the lifecycle of the product and identify the need for corrective and preventive action

Support internal or external audits, including preparing responses to audit findings in support of regulatory clearance/approvals

Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance

Maintain and archive company’s regulatory/notified body files, including regulatory submissions, deficiency letters, certificates/licenses, clearances/approvals, and all associated correspondence

Interpret domestic or international laws, guidelines, standards, regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures

Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents, including the Medical Device Directive (MDD), Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope

Conduct regulatory review and/or approve product labeling (IFU, graphic/symbols, UDI) and advertising/promotional materials (brochure) claims to ensure compliance with design outputs and applicable ISO/regulatory requirements

Served as the backup Person Responsible for Regulatory Compliance (PRRC) role mandated in Medical Device Regulations (MDR) EU 2017/745

All other duties as requested by his/her manager

Qualification

Regulatory AffairsQuality Management SystemsTechnical WritingFDA RegulationsEU MDR ComplianceAnalytical SkillsInterpersonal SkillsCommunication SkillsCritical Thinking

Required

3+ years of Regulatory Affairs or Quality System experience in an FDA/EU-regulated environment with working knowledge of FDA 21 CFR part 820/QMSR, EN ISO 13485, and MDD and EU MDR for Class II medical device is required

Bachelor's degree preferably in a scientific discipline such as Science, or Engineering or equivalent experience

Strong regulatory technical writing skills, including authoring U.S 510(k) and EU Technical Documentation

Ability to apply business and Regulatory Affairs ethical standards

Excellent analytical and critical thinking skills

Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization

Strong verbal and written communication skills, including a proven ability to translate technical documentation into effective quality documentation and regulatory submissions

Strong understanding of FDA and EU regulatory process

Good interpersonal skills and able to work well with cross-functional teams

Must be authorized to work in the US