Medical Device Quality and Compliance Experts

Pharmavise Corporation•Maple Grove, MN

3d•Remote

About The 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 www.pharmavise.com We are actively seeking skilled and knowledgeable professionals to join our team as Medical Device Quality and Compliance Experts. Below, you'll find a comprehensive job description detailing the responsibilities, qualifications, and expectations for this role:

Requirements

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.

Nice To Haves

Quality and regulatory certifications (e.g., ASQ CQE, RAC) preferred but not required.

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.