Regulatory Compliance Manager
1 week ago
Job Description
Job Description
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Regulatory Compliance Manager
It will primarily focus on providing specialized support to the regulatory Affairs department regarding EU MDR certification for manufacturing sites. Collaborate with EU MDR Regulatory Affairs department. This role oversees compliance activities within manufacturing operations globally, managing contactors and driving efforts to address deficiencies in alignment with regulatory standards.
Job Summary:
The Regulatory Compliance Manager, reporting to the Global Quality Assurance department, plays a pivotal role in supporting Regulatory affairs team in achieving EU MDR certification for manufacturing operations. This role oversees two contractors and focuses on ensuring compliance within manufacturing operations, collaborating closely with cross-functional teams to resolve deficiencies and maintain regulatory conformity.
Essential Functions & Accountabilities:
Liaison with RA and MFG Operation sites QA Leaders.
Collaborate with RA to align manufacturing with regulatory submissions and strategies including new regulatory requirements, deficiency management and remediation activities to ensure compliance with external requirements such as the MDR.
Ensure global quality standards and regulatory requirements consistency and adherence across all manufacturing sites.
Supervise and guide contractors, ensuring alignment with project goals and objectives.
Developing and implementing processes for gathering information about potential risks to ensure promptly resolution.
Conducting investigations into any potential or actual deficiency or deviation to a requirement
Support the improvement of the Company’s quality system, and work in conjunction with the company employees to ensure ISO 13485, MDSAP, and FDA QSR compliance for devices.
Reviewing, revising, and updating policies, procedures, and guidelines to ensure that they comply with current requirements and regulations.
Enhance knowledge by educating teams on regulatory requirements.
Qualifications:
Excellent in oral/ written communication skills in both English and Spanish languages.
Ability to read and understand highly technical material.
Proficient knowledge of Medical Devices quality standards and regulations (GMPs/QSR) and best practices.
Leadership, collaborative and collaborative.
Intermediate skill in the use of Excel, Word, and PowerPoint; advanced preferred.
Analytical and critical thinking skills.
Strong organizational and time-management skills.
Project and resources management
Conflict resolution skill
Ability to train and educate others.
Initiative-taking, self-starter, and responsible person.
Experience:
5+ years or more experience in a medical device in a similar position.
Education:
Bachelor’s degree in business administration or science or related experience in regulatory compliance environment.
#J-18808-Ljbffr
-
Regulatory Compliance Manager
1 week ago
De Pere, United States CareerBuilder Full timeJob Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a...
-
Grants Management Consultant
1 week ago
De Pere, United States AGC CONSULTING LLC Full timeJob Description Job Description SUMMARY OF RESPONSIBILITIES The Grant Manager will be assigned to one of our clients in the role of FEMA Public Assistance Finance Subject Matter Expert (SME) to provide technical support in the Disaster Recovery Grant Claims Review Services after Hurricanes Maria and Fiona and to promote accountability and compliance in...
-
Real Estate Investment Project Manager
Found in: Talent US C2 - 1 week ago
De Pere, United States Easy Home Sale Full timeJoin our team at Easy Home Sale, a reputable company located in De Pere, WI, as we search for a talented and reliable Project Manager. As the Project Manager, your main role will involve efficiently overseeing the full life cycle of real estate projects, from inception to successful completion. The ideal candidate will collaborate closely with the team to...
-
Real Estate Investment Project Manager
1 week ago
De Pere, United States Easy Home Sale Full timeJob DescriptionJob DescriptionJoin our team at Easy Home Sale, a reputable company located in De Pere, WI, as we search for a talented and reliable Project Manager. As the Project Manager, your main role will involve efficiently overseeing the full life cycle of real estate projects, from inception to successful completion. The ideal candidate will...
-
Project Manager
23 hours ago
De Pere, United States Validation & Engineering Group Inc. Full timeJob Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a...
-
Data Integrity Specialist
1 week ago
De Pere, United States CareerBuilder Full timeJob Description Job Description PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the...
-
Stability Program Project Manager
1 week ago
De Pere, United States CareerBuilder Full timeJob Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a...
-
Operations Manager
2 weeks ago
De Pere, United States Communications Engineering Company Full timeJob DescriptionJob DescriptionOBJECTIVE:As an Operations Manager you will be an integral part of the CEC team. We help customers run their organizations better through the technology solutions we provide-and you can be part of this essential mission. The Operations Manager leads, supervises, and recruits field staff and PMO personnel to ensure optimal...
-
QA Analyst I
1 week ago
De Pere, United States MultiPlan Full timeImagine a workplace that encourages you to interpret, innovate and inspire. Our employees do just that by helping healthcare payers manage the cost of care, improve competitiveness and inspire positive change. You can be part of an established company with a 40-year legacy that helps our customers thrive by interpreting our clients needs and tailoring...
-
QA Analyst I
22 hours ago
De Pere, United States MultiPlan Full timeImagine a workplace that encourages you to interpret, innovate and inspire. Our employees do just that by helping healthcare payers manage the cost of care, improve competitiveness and inspire positive change. You can be part of an established company with a 40-year legacy that helps our customers thrive by interpreting our clients needs and tailoring...
-
HIMS Forms and Regulatory Operations Manager
2 weeks ago
Wilmington, DE, United States ChristianaCare Full timeDo you want to work at one of the Top 100 Hospitals in the nation? We are guided by our values of Love and Excellence and are passionate about delivering health, not just health care. Come join us at ChristianaCare!ChristianaCare, with Hospitals in Wilmington and Newark, DE, as well as Elkton, MD, is one of the largest health care providers in the...
-
Taco Bell
2 weeks ago
De Pere, United States Seasoned Full timeTaco Bell De Pere is currently hiring a full time or part time Restaurant Supervisor for our De Pere, WI location. A Restaurant Supervisor should not only supervise their team but lead it to acheive their goals. A Restaurant Supervisor will assist in the planning and management at Taco Bell De Pere in order to achieve customer satisfaction, quality service,...
-
Taco Bell
1 week ago
De Pere, United States Taco Bell Full timeTaco Bell De Pere is currently hiring a full time or part time Restaurant Supervisor for our De Pere, WI location. A Restaurant Supervisor should not only supervise their team but lead it to acheive their goals. A Restaurant Supervisor will assist in the planning and management at Taco Bell De Pere in order to achieve customer satisfaction, quality service,...
-
Project Lead Estimator
4 days ago
De Pere, United States Validation & Engineering Group Inc. Full timeJob Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a...
-
Restaurant Supervisor
1 week ago
De Pere, United States Taco Bell- De Pere Full timeTaco Bell De Pere is currently hiring a full time or part time Restaurant Supervisor for our De Pere, WI location. A Restaurant Supervisor should not only supervise their team but lead it to acheive their goals. A Restaurant Supervisor will assist in the planning and management at Taco Bell De Pere in order to achieve customer satisfaction, quality service,...
-
Restaurant Supervisor
1 week ago
De Pere, United States Taco Bell- De Pere (Monroe Rd) Full timeTaco Bell- De Pere (Monroe Rd) is currently hiring a full time or part time Restaurant Supervisor for our De Pere, WI location. A Restaurant Supervisor should not only supervise their team but lead it to acheive their goals. A Restaurant Supervisor will assist in the planning and management at TacoBell- De Pere (Monroe Rd) in order to achieve customer...
-
Taco Bell
1 week ago
De Pere, United States Taco Bell Full timeTaco Bell- De Pere (Monroe Rd) is currently hiring a full time or part time Restaurant Supervisor for our De Pere, WI location. A Restaurant Supervisor should not only supervise their team but lead it to acheive their goals. A Restaurant Supervisor will assist in the planning and management at Taco Bell- De Pere (Monroe Rd) in order to achieve customer...
-
Consultant (Contractor)
1 week ago
De Pere, United States CareerBuilder Full timeJob Description Job Description Are you ready? Are you ready to belong to a highly creative, imaginative team that chases curiosity and embraces intuition to perform assertively every-day? If so, On Point Strategy might be the place for you. Check out our outstanding position as a consultant, and dare to make a difference with your knowledge, experience,...
-
Transmission Engineer
1 week ago
De Pere, United States CareerBuilder Full timeAbout Us Groundbreaker. Game changer. Pioneer. TRC has long set the bar for clients who require more than just engineering, combining science with the latest technology to devise innovative solutions that stand the test of time. From pipelines to power plants, roadways to reservoirs, schoolyards to security solutions, clients look to TRC for breakthrough...
-
De Pere, United States Prevea Health Full timeBC Therapist (RESIDENCY) Come work where we specialize in you! We have nearly 2,000 reasons for you to consider a career with Prevea Health-they're our employees. We're an organization that values kindness, responsibility, inclusivity, wellness and inspiration. At Prevea, we provide continuous education, training and support so every member of the team...