Medical Device Quality and Compliance Experts

Pharmavise Corporation; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

PharmaviseConsulting Corp. is hiring a Medical Device Quality and Compliance Expert for a remote role in the United States. You will lead QMS activities, develop compliance strategies, and support regulatory submissions with FDA and notified bodies.

Ideal candidates hold a bachelor’s in engineering or life sciences, 8+ years in medical device quality/regulatory roles, and strong ISO 13485, FDA QSR, and EU MDR knowledge. Excellent communication and cross-functional leadership are essential.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field.
• Minimum of 8 years in quality assurance and regulatory compliance in medical devices.
• In-depth knowledge of ISO 13485, FDA QSR, and EU MDR.
• Experience leading QMS implementations and maintaining compliance in regulated environments.
• Strong understanding of ISO 14971 risk management principles.
• Excellent communication and interpersonal skills for regulatory discussions.

Responsibilities

• Lead and oversee QMS activities for medical device products across the lifecycle.
• Develop and implement quality and compliance strategies per ISO 13485, FDA QSR, MDR.
• Conduct risk assessments and mitigation for quality and compliance issues.
• Provide guidance on regulatory submissions and regulatory agency interactions.
• Lead and support internal and supplier audits and regulatory inspections.
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs to meet objectives.
• Stay updated on regulatory trends and update QMS processes accordingly.

Skills

Quality assurance

Regulatory compliance

QMS leadership

ISO 13485

FDA QSR

EU MDR

Risk management

Audits

Cross-functional leadership

Education

Bachelor’s in engineering, life sciences, or related field

Job description

This is a remote position.

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

Visit us at We are actively seeking skilled and knowledgeable professionals to join our team asMedical Device Quality and Compliance Experts. Below, you'll find a comprehensive job description detailing the responsibilities, qualifications, and expectations for this role:

Responsibilities

• Lead and oversee quality management system (QMS) activities for medical device products throughout the product lifecycle.
• Develop and implement quality and compliance strategies to ensure adherence to regulatory requirements, standards, and guidelines (e.g., ISO 13485, FDA QSR, MDR).
• Conduct risk assessments and mitigation activities to identify and address potential quality and compliance issues.
• Provide guidance and support on regulatory submissions and interactions with regulatory agencies (e.g., FDA, notified bodies).
• Lead and support internal and external audits, including supplier audits and regulatory inspections.
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams to ensure quality and compliance objectives are met.
• Stay abreast of emerging regulatory trends and changes affecting the medical device industry and proactively implement necessary updates to QMS processes and procedures.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
• Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry.
• In-depth knowledge of relevant quality standards and regulations, including ISO 13485, FDA QSR, and EU MDR.
• Experience leading quality management system implementations and maintaining compliance in a regulated environment.
• Strong understanding of risk management principles and methodologies (e.g., ISO 14971).
• Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory requirements and concepts.
• Proven ability to lead and influence cross-functional teams and drive quality and compliance initiatives to completion.
• Quality and regulatory certifications (e.g., ASQ CQE, RAC) preferred but not required.

This is a challenging and rewarding opportunity for individuals passionate about ensuring the safety, efficacy, and quality of medical devices.

Competitive compensation and benefits packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting Corp. is an equal opportunity employer.

We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients.

When you joinPharmavise, you become part of a team that values Excellence Through Quality.

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