Regulatory Affairs Leader - Medical Devices
Mindray DS USA, Inc.
Mindray DS USA, Inc. is looking for a Manager, Regulatory Affairs located in Mahwah, NJ. This pivotal role involves ensuring compliance with U.S. FDA and Health Canada regulations while managing complaint handling and regulatory submissions. You will supervise a team and provide regulatory support across departments. The ideal candidate has 8–10 years of experience in the medical device industry, strong leadership skills, and a proven track record managing FDA inspections and submissions. A competitive compensation package and comprehensive benefits are offered. #J-18808-Ljbffr Mindray DS USA, Inc.
- BD in the United States is seeking a Quality Assurance leader to drive CAPA, audits, and quality-system activities at the Franklin... ...BS in Engineering or related field and at least eight years in medical device or related industries. You will coordinate with internal and external...Medical device
- ...drive compliance, CAPA leadership, audits, and continuous improvement at a major manufacturing site. The role requires 8+ years in medical devices or related industries and strong knowledge of 21CFR820, ISO 13485, MDD/MDR, and MDSAP. You will lead CAPA and audit programs,...Medical device
- ...managing medium to large projects. The ideal candidate will have extensive project management experience, particularly in the medical device industry, and will work closely with cross-functional teams to ensure project success. The role demands proficiency in project...Medical deviceRemote job
- ...of patient care. Mindray is a global leader in medical technology, delivering advanced patient... ...Job Summary The Manager, Regulatory Affairs oversees key regulatory functions that... ...with U.S. FDA and Health Canada medical device regulations. This role manages complaint...Medical deviceWork at officeWorldwide
- ...Overview: Role: Lead Quality Engineer - Medical Devices & Compliance Location: Franklin Lakes, NJ Duration: 6 months Quality... ...• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards. • Collaborate with cross-functional teams...Medical device
- ...rigorous documentation. The ideal candidate will bring at least 6 years of experience in product design, particularly within the medical devices sector, and possess a Bachelor’s degree in engineering. Strong statistical analysis skills and effective communication...Medical deviceContract work
- ...candidate will have a minimum of 2 years of experience in quality inspection, preferably within the pharmaceutical, biotech, or medical device industries. Key responsibilities include conducting 100% visual inspections and ensuring compliance with GMP standards. #J-188...Medical deviceContract work
- ...Technician located in Franklin Lakes, NJ for a 12+ month contract. The role involves performing bench-level mechanical tests on medical devices, ensuring compliance with standard procedures. Candidates must have strong attention to detail and good communication skills....Medical deviceContract work
- ...Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Quality Level of Experience... ...WW Supplier Quality Assurance, Research and Development, Regulatory Affairs, and additionally to corporate functions, regulatory agencies...Medical deviceContract workLocal areaDay shift
- ...This position is responsible for the support of regulatory submissions required to market medical devices in the U.S., Europe and other international markets and sustaining-engineering related regulatory affairs activities for BD Diabetes Care. Requires the analysis...Medical deviceContract work
- ...of the largest global medical technology companies in... ...of the prime Medical Affairs contacts to a pharma partner... ...as a technical leader on a cross-functional... ...technical design linked to device usability.Work closely... ...and Development, Regulatory Affairs, Marketing, and...Medical deviceLocal area
- ...lines. Serve as a multi-functional team leader for quality improvement teams assuring... ...for assuring that quality standards and regulatory compliance activities are consistent... ...and standards broadly recognized by the medical device industry. The incumbent will be responsible...Medical device
- ...Job Title - Senior Regulatory Affairs Specialist Location - Franklin Lakes, NJ [No Remote... ...Duration – 12+ Months Client: Medical Device Company Employment Type: Contract... ...learn and work alongside inspirational leaders and colleagues who are equally passionate...Medical deviceContract workWork experience placementRemote workWorldwideFlexible hours
- ...or develop products. You will set pricing strategies, monitor competitors, and translate customer needs into strategic plans and launches. The role requires strong presentation and analytical skills, with a track record in marketing or medical devices. #J-18808-Ljbffr...Medical device
$80k - $95k
...among the largest family-owned medical technology companies in the... ...— helping ensure our medical devices meet the highest standards of safety, reliability, and regulatory requirements throughout the product... ...Collaborate with Regulatory Affairs on Instructions for Use (IFUs)...Medical device$170k - $190k
A leading medical technology company is seeking a Senior Product Manager responsible for the lifecycle of a cardiovascular product portfolio. The role demands extensive experience in medical devices and strong skills in strategic thinking and analytics. Key responsibilities...Medical device- ...Duration: 6 Months contract Total Hours/week: 40.00 Client: Medical Device Company Job Category: Sales Support Level of Experience:... ...offer technical counsel to Sales, Marketing, R&D, QA, and Regulatory Affairs. Primary Duties, Responsibilities & Authorities Conducts...Medical deviceContract work
$102.6k - $171k
...communication with stakeholders, ensuring regulatory and quality objectives are met on time.... ...in at least one discipline (Regulatory Affairs, Quality Assurance, or other quality... ...Preferred: experience in a regulated industry (medical devices highly preferred). Must be able to...Medical deviceFor contractorsRemote work- Job Title Sr. R&D Engineer Location Franklin Lakes, NJ Duration 12+ Months Contract Client Medical Device Company Job Category Research & Development Employment Type Contract on W2 (Need US Citizens or GC Holders Only) Description Pre‑qualifying questions submitted...Medical deviceContract workFlexible hours
$230.3k - $368.5k
...purpose BD is one of the largest global medical technology companies in the world.... ...Job Description The Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President... .... Minimum of 5 years in Medical Device industry, with roles in Regulatory Affairs...Medical deviceDaily paidTemporary workWork at officeFlexible hours- ...Months Total Hours/week 40 Shift 1st Shift Client Medical Devices Company Description The R&D Scientist II reports... ...with R&D-Engineering, Marketing, Medical Affairs, Manufacturing, Quality and Regulatory Affairs. Participate in intellectual property growth...Medical deviceContract workShift workDay shift
- A leading medical device firm is seeking an Entry Level Clinical Trial Assistant in Franklin Lakes, NJ. Ideal candidates will have 2 years of experience in clinical trials and a BA/BS in a related field. This role involves managing study inventory, assisting in kit assembly...Medical device
- ...: 12+ Months Contract. Total Hours/week: 40.00. This laboratory technician will mainly perform bench-level mechanical tests of medical devices, following written test procedures and not requiring constant supervision. Typical work includes: Hands‑on measurement of tension...Medical deviceContract workShift work
- A medical devices company is seeking an LMS Coordinator/Administrator to manage and optimize the SuccessFactors Learning Management System. The role involves maintaining master data, ensuring data accuracy and compliance, and troubleshooting LMS issues. Candidates should...Medical deviceContract work
$100k
...pricing agreements, and other contractual documents within the medical device space. What You’ll Do Develop, review, and manage... ...Collaborate cross-functionally with Sales, Legal, Finance, Regulatory, and Marketing to ensure proposals and contracts align with company...Medical deviceContract work- ...Entry Level Laboratory Technician in Franklin Lakes, NJ, for a 12-month contract. The role involves performing mechanical tests of medical devices in compliance with strict procedural regulations. Candidates should have a degree in Mechanical or Biomechanical engineering...Medical deviceContract work
- ...strategies and manage cross-functional projects. The ideal candidate should possess a Bachelor's degree with 6+ years of experience, preferably in medical device marketing or sales. The position offers comprehensive health and financial benefits. #J-18808-Ljbffr PowerToFlyMedical device
$75k - $85k
VB Spine is seeking a Quality Systems Specialist to enhance their Quality Management System. You will ensure compliance with medical device regulations while improving quality and safety standards. The ideal candidate will have a Bachelor's degree and experience with quality...Medical device- ...relevant experience, and proficiency in SAP or JDE. A focus on customer satisfaction and operational efficiency is crucial for success in this position. Consider this opportunity to advance your career within the medical devices industry. #J-18808-Ljbffr MillenniumSoft IncMedical device
$45 - $55 per hour
...Management Specialist in Mahwah, NJ. This role focuses on facilitating document changes and ensuring compliance with regulatory requirements for medical devices. Candidates should have a BS in a related field and at least 3 years of experience in a regulated industry. The...Medical deviceHourly payImmediate start
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