Vice President Regulatory Affairs Quality Assurance
3 weeks ago
Responsibilities:
Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements.
Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA.
Provide guidance and expertise on regulatory requirements, standards, and best practices related to PMA submissions.
Collaborate with cross-functional teams to gather and compile necessary data and documentation for PMA submissions.
Ensure compliance with regulatory requirements and standards throughout the PMA process, from pre-submission to post-approval activities.
Manage interactions with regulatory agencies and represent the company in PMA-related meetings and communications.
Establish and maintain a robust quality management system (QMS) to support PMA submissions and ongoing compliance.
Lead quality assurance initiatives to maintain high standards of product quality and safety throughout the PMA process.
Provide leadership, mentorship, and development opportunities for the regulatory affairs and quality assurance teams.
Qualifications:
Bachelors degree in a scientific or engineering discipline; advanced degree preferred.
Minimum of 12 years of experience in regulatory affairs and quality assurance within the medical device industry.
Proven track record of successful PMA submissions and approvals for medical devices.
Thorough understanding of FDA regulations, guidance documents, and PMA requirements.
Strong leadership skills with the ability to drive results and foster a culture of compliance and quality.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Strategic thinker with the ability to develop innovative regulatory strategies and solutions.
#J-18808-Ljbffr
-
Quality Assurance Manager
1 week ago
Trenton, United States DIGI AMERICA INC Full timeOverview At DIGI we are always Searching for a New Balance. Our vision is to create new standards. Using original technology, we create new standards for the market - and when these new standards become commonplace, we break with convention and take on the challenge of creating the next standard. We are continually striving to create a new balance. We are...
-
Quality Assurance Specialist
1 month ago
Trenton, United States TCG GreenChem Inc Full timeJob DescriptionJob DescriptionJob SummaryLeadership responsibility to manage quality assurance and compliance programs and business excellence efforts at TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate development requirements in drug substance development process. Assist in overseeing practices...
-
Trenton, United States Endo International plc Full timeWhy Endo? We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our...
-
Vice President of Total Rewards
1 month ago
Trenton, United States GQR Full timePosition Overview: As the Vice President of Total Rewards, you will be responsible for leading the development, implementation, and management of comprehensive compensation and benefits programs. Reporting directly to the Chief Human Resources Officer, you will play a crucial role in attracting, retaining, and motivating top talent within the organization...
-
US Basel IV Regulatory Capital Reporting AVP
2 weeks ago
Trenton, United States Barclays Full timeUS Basel IV Regulatory Capital Reporting Assistant Vice President Whippany, NJ As a Barclays US Basel IV Regulatory Capital Reporting Assistant Vice President (AVP), you will be working in the Regulatory Capital Team and will be tasked with the development and on-going circulation and reporting of both point in time and Comprehensive Capital Analysis and...
-
Quality Assurance Manager
5 days ago
Trenton, United States X4lifesciences Full timeThere is an exciting opportunity for a Quality Assurance Manager for a boutique Clinical Trial sourcing Pharmaceutical company based in New Jersey! The successful candidate must have a strong background in secondary Pharmaceutical packaging & labelling. Experience within clinical trial sourcing would also be advantageous! QA Manager – Key Responsibilities...
-
Director, Global Regulatory Lead
4 days ago
Trenton, United States Rocket Pharmaceuticals Full timeWork at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for...
-
Manager, GCP Quality Assurance
5 days ago
Trenton, United States Aquestive Therapeutics Full timeJob Summary: This position is responsible for providing robust quality oversight throughout Aquestive's development program. The successful candidate will provide quality expertise to manage and improve processes across Aquestive's development program, ensuring compliance with Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Preclinical stage...
-
Quality Assurance Manager
5 days ago
Trenton, United States Clinical Dynamix Full timeQuality Assurance Manager Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good...
-
Vice President, Head of Financial Planning
4 days ago
Trenton, United States Everest Group Full timeTitle: Vice President, Head of Financial Planning & Analysis Company: Everest Insurance Company Job Category: Finance Job Description: About Everest: It’s an exciting time for Everest Group, Ltd. (“Everest”)! As we continue on our journey, we see significant opportunity ahead of us to expand our reach, build diversity, and enhance our capabilities in...
-
Director, State Government Affairs
4 days ago
Trenton, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Sr Medical Director/Medical Director
4 days ago
Trenton, United States Meet Full timeJob Description: Sr Medical Director/Medical Director, Medical Affairs Overview: Join our client's team as a Sr Medical Director/Medical Director, Medical Affairs, where you will provide medical, scientific, strategic, and operational leadership. You will play a key role in activities such as generating clinical and scientific data, enhancing therapeutic...
-
Communications & Community Affairs Manager
5 days ago
Trenton, United States Occidental Petroleum Corporation Full timeJob Description - Communications & Community Affairs Manager (00030261) Communications & Community Affairs Manager - 00030261 Our greatest asset has been and will continue to be our people. We are looking for an experienced and motivated individual to fill the position of Manager, Communications & Community Affairs based in New Jersey. The Manager will drive...
-
Thoracic Surgeon
3 weeks ago
Trenton, United States Inspire Healthcare Full timeDescription: Physician shall devote no fewer than 40 clinical hours per week to the role of thoracic surgeon. Provide thoracic surgery consultation at hospitals facilities, and in an office or offices established for her to consult with patients. Perform the full scope of thoracic surgical services, including but not limited to minimally invasive/robotic...
-
Vice President, Sales- Real World Data/evidence
47 minutes ago
Trenton, United States Clarivate Full timeIf you are passionate about driving growth through strategic sales efforts in the Real-World Data space and thrive in a dynamic, collaborative environment, we invite you to join our team and be a driving force in our success. As the **Vice President** of Sales** for Real World Data, you will be responsible for developing and executing the sales strategy,...
-
Vice President, Finance
5 days ago
Trenton, United States Women Leading Travel & Hospitality Full timeManage the Accounting function, including P&L review and forecasting. Prepare financial and capital budgets annually. Ensure that financial records are accurate and maintained up to date. Review all monthly and weekly P&L estimates. Review all wire payments. Responsible for accurate preparation and distribution of monthly, quarterly, and annual financial...
-
Senior Director, Marketing
2 days ago
Trenton, United States Cosette Pharmaceuticals Inc. Full timeCosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality...
-
Compliance Specialist
2 weeks ago
Trenton, United States Jacent Strategic Merchandising Full timeJacent Strategic Merchandising Compliance Specialist Cinnaminson , New Jersey Apply Now As a Compliance Specialist in the consumer products industry, your primary responsibility is to ensure that the organization complies with relevant laws, regulations, and industry standards governing the manufacturing, labeling, and distribution of consumer goods. You...
-
Regulatory Specialist
5 days ago
Trenton, United States Hackensack Meridian Health Full timeHackensack Meridian Health Regulatory Specialist Hackenack , New Jersey Apply Now Our team members are the heart of what makes us better.At Hackensack Meridian Health we help our patients live better, healthier lives and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive...
-
Software Quality Assurance Director
4 weeks ago
Trenton, United States P. Chappel Associates Inc Full timeOur client is a growing security-focused network management company located in central NJ. This is a highly visible opportunity for a QA pro to really make an impact and grow. The SQA Director will bring in new technology as well as manage processes and SQA teams in the US and offshore. These teams perform automated and manual testing of software...