Medical Device Quality and Compliance Experts
Pharmavise Corporation · Remote · remote · Posted 36d ago
Undisclosed8–13 yrsfulltimeSourced from
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About this role
Job Summary
Responsibilities
Qualifications
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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.
We are actively seeking skilled and knowledgeable professionals to join our team as Medical Device Quality and Compliance Experts. Below, youll 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 RD, 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
- Bachelors 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.
Be part of our network of Subject Matter Experts.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
ISO 13485Regulatory AffairsauditsRACCompensation And BenefitsBiotechnologyQuality AssuranceMedical DevicesManufacturingcomplianceQSRPharmaceuticalLife Sciencesquality managementCommunication And Interpersonal Skills