Description: 186 Regulatory Affairs Project Manager – Medical Device (186 RA) There are currently 7 similar QA/RA, Clinical Affairs and Compliance positions available in FL, NY, WA, OR, TX, IN, TN. Please review other positions and geographies online at www.LegacyMedSearch.com
The RA Project Manager will implement strategies and activities required to obtain regulatory approval for new and revised implantable devices and ensure compliance to all US, EU and Regulatory and QA requirements as well as to corporate policies and procedures regarding submissions and other requirements for market approval of medical devices, applying scientific principles.
Primary Responsibilities
• Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process
• Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files and Design Dossiers
• Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications
• Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers
• Address and advise teams on appropriate pathways to market
• Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures.
• Review and approve change requests with regard to US and EU Regulatory requirements
• Prepare and update US product listings and EU registrations
• Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management
• Develop, implement and maintain regulatory SOP’s
• Conduct quality and regulatory training
Qualifications
BA/BS in Scientific discipline
- 7 years experience in RA
- RAC certification desired; quality assurance experience a plus
- 510(k), IDE, PMA (original/revision/supplements) preparation experience
- Preparation of EU Technical Files and Design Dossiers Minimum 4-5 years experience in FDA and EU regulated medical device industry
- Working knowledge of FDA and EU Medical Device Regulations
- Direct interaction with FDA reviewers/inspectors
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Job Title: Assistant VP, Quality Murphy Medical Center in the beautiful
Company: Location: Asheville, NC
Description:
Assistant VP, Quality Murphy Medical Center in the beautiful western NC mountains is seeking a full time Asst. VP, Quality to oversee the facility's Compliance Dept. BS in Nursing or healthcare related field required. MS preferred. Knowledge of regulatory compliance issues such as: CMS, the Joint Commission, NCDOH, NCBON and a minimum of 5 years experience in management is required. Human Resources Murphy Medical Ctr 4130 US Hwy 64 East Murphy, NC 2890 Register to View fax Register to ViewRegister to View medical.org Source - Asheville Citizen Times - Asheville, NC
Job Title: Vice President Quality, Heart Valve Therapy
Company: Edwards Lifesciences LLC
Location: Irvine, CA
Description:
st1\:*{} Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine , Calif. , Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. Edwards has more than 5,600 employees worldwide, selling medical technologies in nearly 100 countries. The company leverages its research, design, development and marketing expertise through five main product categories: Heart Valve Therapy, Critical Care, Cardiac Surgery, Vascular Therapy, and Transcatheter Valve Interventions. For us, saving lives is not just a slogan – it's what we do. From developing devices that replace a damaged heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life. Vice President Quality, Heart Valve Therapy Opportunity Snapshot : Responsible for overseeing global quality assurance programs and systems in support of the heart valve therapies business unit. Develop and execute the corporate quality strategy and compliance throughout the global HVT organization, and will ensure delivery of quality standards and approaches through a team of quality directors, managers, professionals and line personnel primarily located in Irvine , Singapore and Switzerland . The global scope of the position requires interface with high impact with key opinion leader customers as well as senior management inside and outside the Quality organization, particularly with research and development and manufacturing operations. Our Requirements: · Requires a minimum of fifteen years of quality assurance leadership experience within the medical device industry (preferably cardiac therapy devices). · Will have prior leadership experience preferably in leading a quality function for a division or at the corporate level. Management of quality teams within various global regions and multiple manufacturing sites strongly desired. · A Bachelor's degree in a Scientific, Engineering or related discipline required. A MBA or Master's degree in a related Scientific or Engineering discipline preferred. Six Sigma or related world class manufacturing process excellence certification desirable. · Must be a strong technical contributor and leader in the QA organization, and deemed an expert in all matters relating to global quality assurance and compliance · Effective at leading talent within a culturally diverse, matrixed organizational structure. Able to design and implement quality improvement processes in support of business plans, and effective in resolving product quality issues in collaboration with manufacturing and engineering organizations essential. · Must have knowledge of global quality assurance standards, Good Manufacturing Processes, compliance regulations, statistical methodologies, and TQM strategies. · Requires demonstrated success and work history of positive interactions with FDA and other regulatory authorities. · Must have developed and implemented employee quality training programs. How to Apply : At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website: www.edwards.com OR To apply directly to this position, please click the link below or cut and paste it into your browser : http://www.edwards.com/Careers/reqfinder?urlvariablestring=2675
Job Title: Vice President of Quality
Company: Location: Greenville, SC
Description:
Highly successful pharmaceutical company with new technologies affecting the pharmaceutical industry is looking for a VP of Quality. The position is dedicated specifically to managing the Quality Systems of the company and ensuring consistent adherence to regulatory standards. The VP of Quality is a liaison to state, federal, and international regulatory agencies and certification bodies. All Quality departments, to include Quality Assurance, Quality Control, Process Control and Validation, report directly to this position (approximately 30 individuals). The VP of Quality interacts routinely with the senior management team to design, develop, support and implement innovative improvement projects to drive the company’s success. The VP of Quality will champion the use of Quality Engineering principles to promote continuous improvement methodologies into current Quality Systems. This company is growing steadily and provides a wealth of opportunity for hard-working hands-on individuals interested in being part of a team with clear goals and direction. If you are ready to make a change and are able to do so, please send me your resume in confidence and I will call you to discuss the details of the oppportunity.
Job Title: Vice President Quality, Heart Valve Therapy
Company: Edwards Lifesciences
Location: Irvine, CA
Description:
Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. Edwards has more than 5,600 employees worldwide, selling medical technologies in nearly 100 countries. The company leverages its research, design, development and marketing expertise through five main product categories: Heart Valve Therapy, Critical Care, Cardiac Surgery, Vascular Therapy, and Transcatheter Valve Interventions. For us, saving lives is not just a slogan – it's what we do. From developing devices that replace a damaged heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life. Vice President Quality, Heart Valve Therapy Opportunity Snapshot : Responsible for overseeing global quality assurance programs and systems in support of the heart valve therapies business unit. Develop and execute the corporate quality strategy and compliance throughout the global HVT organization, and will ensure delivery of quality standards and approaches through a team of quality directors, managers, professionals and line personnel primarily located in Irvine, Singaporeand Switzerland. The global scope of the position requires interface with high impact with key opinion leader customers as well as senior management inside and outside the Quality organization, particularly with research and development and manufacturing operations. Our Requirements: · Requires a minimum of fifteen years of quality assurance leadership experience within the medical device industry (preferably cardiac therapy devices). · Will have prior leadership experience preferably in leading a quality function for a division or at the corporate level. Management of quality teams within various global regions and multiple manufacturing sites strongly desired. · A Bachelor's degree in a Scientific, Engineering or related discipline required. A MBA or Master's degree in a related Scientific or Engineering discipline preferred. Six Sigma or related world class manufacturing process excellence certification desirable. · Must be a strong technical contributor and leader in the QA organization, and deemed an expert in all matters relating to global quality assurance and compliance · Effective at leading talent within a culturally diverse, matrixed organizational structure. Able to design and implement quality improvement processes in support of business plans, and effective in resolving product quality issues in collaboration with manufacturing and engineering organizations essential. · Must have knowledge of global quality assurance standards, Good Manufacturing Processes, compliance regulations, statistical methodologies, and TQM strategies. · Requires demonstrated success and work history of positive interactions with FDA and other regulatory authorities. · Must have developed and implemented employee quality training programs. How to Apply : At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website: www.edwards.com OR To apply directly to this position, please click the link below or cut and paste it into your browser : http://www.edwards.com/Careers/reqfinder?urlvariablestring=2675
Job Title: Vice President of Quality
Company: Management Recruiters of Lake County
Location: Spartanburg, SC
Description:
Highly successful pharmaceutical company with new technologies affecting the pharmaceutical industry is looking for a VP of Quality. The position is dedicated specifically to managing the Quality Systems of the company and ensuring consistent adherence to regulatory standards. The VP of Quality is a liaison to state, federal, and international regulatory agencies and certification bodies. All Quality departments, to include Quality Assurance, Quality Control, Process Control and Validation, report directly to this position (approximately 30 individuals). The VP of Quality interacts routinely with the senior management team to design, develop, support and implement innovative improvement projects to drive the company???s success. The VP of Quality will champion the use of Quality Engineering principles to promote continuous improvement methodologies into current Quality Systems. This company is growing steadily and provides a wealth of opportunity for hard-working hands-on individuals interested in being part of a team with clear goals and direction. If you are ready to make a change and are able to do so, please send me your resume in confidence and I will call you to discuss the details of the oppportunity.
Job Title: VP Quality, OptumHealth Care Solutions - 211029
Company: UnitedHealth Group
Location: Golden Valley, MN
Description:
Job Category: Administration Reference Code: 211029 Position Type: Full-time VP Quality, OptumHealth Care Solutions - 211029 Job Description Description SVP Quality, OptumHealth Care Solutions - MN OptumHealth improves the quality and efficiency of health care through personalized, caring and lifelong services for consumers and employers. In this key senior leadership role you will set vision and strategy for Optumhealth Care Solution’s quality program. You will: Lead the continued development, operation and adoption of a quality system that will meet and exceed quality standards such as ISO 9000 Facilitate the documentation of the quality strategy and the tactical steps to execute the strategy Identify systemic opportunities for quality improvement Manage teams of auditors, black belts, green belts (indirectly), policy and procedure experts to continuously improve the quality system Participate on the executive leadership team. Develop, implement, monitor and direct comprehensive customer-driven quality programs that support business segment objectives and result in improved quality, increased customer satisfaction, lowered operating costs, improved production and enhanced levels of performance. Develop industry leading market position in quality management processes and results. Serve as business segment's External Practices Leader for quality strategy and programs with customers, consultants and brokers. Integrate Six Sigma Process Improvement philosophies into the operational initiatives. Keep current with industry and incorporate leading edge quality best practices into our organization. Drive on-going assessment of all business processes to achieve customer satisfaction Qualifications Prior executive quality leadership role Prior manufacturing experience preferred. Experience with ISO 9000 or other quality system standards Demonstrated success and experience in development of quality improvement strategies Demonstrated financial cost savings resulting from quality improvement Demonstrated success in productivity/operational effectiveness 10+ years combined management and process improvement experience Advanced degree in Business preferred. BA degree required. External credentials/certifications for quality management; such as six Sigma, ISO 9001 Strong leadership qualities with excellent interpersonal skills and negotiating skills ~ Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/V UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.