Medical Device Quality and Compliance Expert
P
PharmaviseConsulting Corp.Medical Devices
United StatesContractSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 8 years
- Required Skills
- Quality AssuranceRisk Management
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.
- 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.
View Full Description & ApplyYou'll be redirected to the employer's site
