RA/QA Manager

Summary:

The RA/QA Manager is accountable for maintaining and improving Prospect Life Sciences’ quality management system and providing practical regulatory leadership for Client medical device programs. This hands-on leader supports product development, manufacturing transfer, production, and postmarket activities while ensuring applicable quality and regulatory requirements are met.

The position reports directly to the CEO/President

Key Accountabilities:

RA/QA Functional Group Ownership – 40%

Responsible for PLS QMS effectiveness, regulatory compliance, audit readiness, product quality oversight, and timely execution of Client regulatory and quality deliverables.

Lead, Manage, Develop, and Hold Accountable – 25%

Lead and coach assigned personnel and cross-functional resources; establish priorities, training, performance expectations, and accountability.

Continuous Improvement, Work Documentation, and Procedure Development – 15%

Improve processes, controls, documentation, and regulatory workflows while balancing risk, project schedule, cost, and Client requirements.

Client/Customer Service – 20%

Serve as a trusted Client-facing RA/QA resource, communicating requirements, risks, progress, and practical solutions.

Primary Responsibilities:

RA/QA Functional Group Ownership – 40%

1. Responsible for maintaining the PLS QMS in accordance with ISO 13485:2016, applicable FDA 21 CFR Part 820 QMSR requirements, ISO 14971, and Client-specific quality agreements.

2. Lead document and record control, change control, CAPA, nonconforming product/material review, complaint handling, supplier quality, internal audits, external audits, management review, and inspection readiness.

3. Provide regulatory strategy and execution support for Client products, including device classification, regulatory pathways, labeling assessments, submissions and associated technical documentation, as assigned.

4. Support preparation and maintenance of FDA 510(k), IDE, and other applicable submissions; coordinate regulatory authority responses and Client approvals. Support EU MDR technical documentation and conformity activities when applicable.

5. Provide quality oversight for design and development, design reviews, requirements traceability, risk management, verification and validation, design transfer, manufacturing/process validation, and product changes.

6. Assess product and process issues for regulatory impact, reportability, product safety, and Client/legal manufacturer notification obligations; coordinate decisions with the responsible legal manufacturer.

7. Plan and conduct internal and supplier audits; lead responses to FDA, ISO 13485 certification-body, and Client audits and ensure effective closure of findings.

8. Develop and maintain RA/QA operating objectives, metrics, and resource plans in collaboration with CEO, Product Development, Manufacturing Transfer, Production leadership.

Lead, Manage, Develop, and Hold Accountable – 25%

1. Lead, train, and coach assigned RA/QA personnel; reinforce company values, ownership, timely communication, and disciplined execution.

2. Hold monthly one-on-ones, quarterly performance/development reviews, and timely performance feedback; identify training needs and ensure documented competence.

3. Coordinate workload, staffing priorities, and cross-functional issue resolution; escalate material compliance, safety, resource, or schedule risks promptly.

4. Partner with leadership on recruiting, associate development, performance management, and compensation recommendations.

Continuous Improvement, Work Documentation, and Procedure Development – 15%

1. Create, review, approve, and improve SOPs, forms, work instructions, quality records, training materials, and regulatory procedures.

2. Use audit trends, CAPA effectiveness, complaint data, supplier performance, and process metrics to identify and prioritize risk-based improvements.

3. Collaborate with Engineering and Operations on manufacturability, process controls, validation, inspection, acceptance criteria, and production readiness.

4. Evaluate QMS tools and workflows that improve compliance, document integrity, efficiency, and on-time project execution.

Client/Customer Service – 20%

1. Act as a primary RA/QA liaison with Clients and project managers; translate product and regulatory requirements into clear action plans and deliverables.

2. Communicate compliance risks, findings, regulatory assumptions, scope changes, and corrective actions early and constructively.

3. Understand Client device intended use, development maturity, manufacturing model, and target markets to provide appropriate regulatory and quality guidance.

4. Coordinate Client approvals and legal-manufacturer responsibilities under applicable quality agreements; maintain responsiveness and professional trust.

Education and Experience

· Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline required.

· Minimum eight (8) years of progressive experience in the medical device industry in quality assurance, quality engineering, regulatory affairs, or a combination of these functions.

· Demonstrated direct experience with medical device products, including product development/design controls, manufacturing transfer, process validation, production quality, or postmarket product support; experience limited to general document administration is insufficient.

· Hands-on experience implementing and maintaining an ISO 13485 medical device QMS, leading CAPA and audits, and applying FDA medical device regulatory requirements.

· Experience preparing or materially supporting medical device regulatory submissions and technical documentation, and communicating with Clients or regulatory stakeholders.

· Prior team leadership, functional ownership, or cross-functional project leadership experience required.

Other Qualifications

· Working knowledge of FDA 21 CFR Part 820 QMSR, ISO 13485:2016, ISO 14971, and relevant FDA premarket and postmarket requirements; familiarity with EU MDR 2017/745 preferred.

· Ability to apply risk-based judgment to device design, verification/validation, sterilization and packaging validation, supplier controls, and manufacturing changes.

· Preferred certifications: ASQ CQE or CQA, Regulatory Affairs Certification (RAC), ISO 13485 Lead/Internal Auditor, or comparable qualification.

· Strong technical writing, interpersonal communication, organization, problem-solving, and Microsoft Office skills; ability to manage competing Client priorities.