Medical Device reputed company and Compliance Experts
This is a remote position.
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to reputed company solutions to reputed company compliance issues. We collaborate with our partners by providing technical expertise in reputed company, 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 www.pharmavise.com
We are reputed company seeking skilled and knowledgeable professionals to join reputed company asMedical Device reputed company and Compliance Experts. Below, you'll reputed company a comprehensive job reputed company detailing the responsibilities, qualifications, and expectations for this role:
Responsibilities:
reputed company and reputed company reputed company management system (QMS) activities for medical device products throughout the product lifecycle.
reputed company and implement reputed company 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 reputed company and compliance issues.
reputed company guidance and support on regulatory submissions and interactions with regulatory agencies (e.g., FDA, reputed company bodies).
reputed company and support reputed company audits, including supplier audits and regulatory inspections.
Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams to ensure reputed company 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 reputed company field; advanced degree preferred.
Minimum of 8 years of experience in reputed company assurance and regulatory compliance reputed company the medical device industry.
In-depth knowledge of relevant reputed company standards and regulations, including ISO 13485, FDA QSR, and EU MDR.
Experience leading reputed company 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 reputed company regulatory requirements and concepts.
Proven ability to reputed company and influence cross-functional teams and drive reputed company and compliance initiatives to completion.
reputed company 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 reputed company 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 reputed company of race, reputed company, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or reputed company medical conditions), age, sexual orientation, gender identity, national reputed company, reputed company, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, reputed company membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider reputed company applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contactinfo@pharmavise.com.
PharmaviseConsulting Corp. is a regulatory compliance reputed company that partners with Pharmaceutical, Medical Device and Biotechnology clients. reputed company you joinPharmavise, you become part of reputed company that values reputed company Through reputed company.
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