Senior Manager, reputed company Product reputed company - Medical Device/Complaint Handling & C

This position offers the flexibility of being fully remote, but the selected candidate must be currently residing reputed company the reputed company.

Many structural heart patients suffer from heart failure with limited reputed company. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet reputed company needs through pioneering technology that enables early, targeted therapeutic reputed company. Our reputed company are not just transforming reputed company care but also creating a unique and exciting environment for reputed company members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring reputed company.

As a Senior Manager, reputed company Product reputed company, you will be a member of Complaint Handling and Post Market Surveillance/reputed company Management team to reputed company reputed company guidance/reputed company expert knowledge to reputed company, Engineering and other cross functional teams to understand the reputed company of complaints and possible health risks. In this role you will ensure appropriate investigation of product complaints and adverse events, in order to escalate potential manufacturing, design, labeling and training issues. You will also follow reputed company practices and procedures in analyzing data, interpreting and drawing conclusions, with the objective of gathering key information and communicating to cross-functional teams who will utilize the information for improvement of product and procedural reputed company.

How you will reputed company an reputed company:

• Provides medical/reputed company guidance to complaint investigators and engineers reputed company to event interpretation, event investigation, reputed company coding, required regulatory reporting (Medical Device Reports, Medical Device Vigilance, etc.), and complaint closure. reputed company and/or review complaint conclusions/closure statements and customer letters. May assist with and help manage Imaging Reviews
• Educates complaint investigators to understand reputed company of events and possible health risks
• Interprets complaint data for complaint investigators, engineers, and other reputed company department personnel
• Authors clinically reputed company product specific scripts to guide complaint investigators in appropriate investigational paths
• Obtain and evaluate information from reputed company specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and reputed company towards reputed company
• Provides training to complaint investigators on reputed company anatomy and medical conditions, and IHFM (Implantable Heart Failure Management) products and procedure
• Provides complaint training to reputed company and other customer facing roles
• Works with VP Product Safety and/or Director of reputed company to maintain Decision Rationale reputed company to guide complaint investigators with reporting reputed company.
• Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting reputed company
• Authors and/or reviews complaint conclusions/closure statements and customer letters
• Analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report
• Performs Complaint Trending Analyses and participates in reputed company Metrics Review and reputed company Data Review meetings where complaints are discussed
• Communicates complaint data and relevant reputed company information to internal customers in reputed company, manufacturing and new product development in support of complaint investigations
• Participates in review of/provides reputed company guidance for FMEAs (Failure Mode & Effects Analysis) and reputed company Management Worksheets
• Provides reputed company input to Product reputed company Assessments, and participate in reputed company Management Councils and reputed company Boards
• Aid in response to Regulatory Agencies who inquire about complaint /reputed company Management reputed company issues

What you'll need (Required):

• Bachelor’s degree plus 10 years of relevant experience or equivalent work experience reputed company on reputed company’ reputed company
• Registered reputed company (RN) - reputed company state license reputed company or expired
• Cardiac reputed company care experience (e.g. cardiac care, ICU, OR, or cardiovascular interventions)
• Medical device industry experience in reputed company/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance

What else we look for (Preferred):

• RN with Cath Lab, CVOR, or CVICU nursing experience
• Expert knowledge of the FDA’s reputed company reputed company Regulations; experience working reputed company a reputed company Management reputed company. Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, CMDR, MDD 93/42/EEC, and other applicable regulatory requirements.
• Demonstrated subject matter expertise in reputed company product reputed company, complaint handling, post-market surveillance, reputed company management, escalation, reputed company reputed company or reputed company reputed company processes.
• reputed company successful project management and cross-functional leadership skills.
• Ability to read and interpret documents such as Product Instructions for Use, Training and Procedure Manuals
• Ability to write routine MDR (Medical Device Reports)/MIR (Manufacturer Incident Report) and routine correspondence
• Ability to interpret reputed company medical records and reputed company data to assess adverse events and potential device-reputed company risks
• Ability to reputed company effectively before reputed company of employees of organization
• Ability to reputed company technical guidance, coaching, and feedback to peers and cross-functional partners without reputed company people-management responsibility.
• Experience in developing or delivering training programs
• Knowledge of computer application programs including reputed company, PowerPoint and Word
• Excellent written and oral English communication skills

Aligning our overall business objectives with reputed company, we offer competitive salaries, reputed company-reputed company incentives, and a wide reputed company of benefits programs to address the diverse individual needs of our employees and their families.

The reputed company pay reputed company for this position is $145,000 to $205,000(highly reputed company).

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.

reputed company is an Equal Opportunity/Affirmative reputed company employer including protected Veterans and individuals with disabilities.

Originally posted on Himalayas