Regulatory Affairs Director jobs in New York
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
Director, Quality and Regulatory Affairs
- Integer Holdings Corporation
-
Alden, NY
FULL_TIME
-
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right- Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Serves as Change Champion for Product Category and respective sites to engage Associates in translating the Quality and Regulatory Vision into reality.
- Recognized as principal Quality contact and advocate to customers in assigned Product Category and represents Quality in Product Category customer business reviews, executive partnership meetings and customer escalation events, establishing and maintaining customer communications and credibility as the Integer champion.
- Directs the management of all business-impacting changes across the sites.
- Leads and is responsible for success of activities to streamline Quality processes to ensure consistency with Integer Business Systems within the Product Category and alignment with global owners of such Quality System processes.
- Leads consolidation and communication of monthly report outs on key customer interactions, including complaint/post market status, Quality agreements, regulatory request status and product submission/certification status.
- Plans, executes, and manages Quality related project activities across the Product Category sites with the site Quality managers.
- Interfaces directly and regularly with internal and external customers. Responsible for projects that are of the highest priority with high visibility by customers. Proactively manages the risk associated with Quality concerns.
- Communicates regularly with executive management and administration regarding the management of current projects; obtains executive management guidance and approval as required
- Reviews and provides guidance on documentation to ensure a high degree of accuracy, completeness, and effectiveness.
- Drives consistent use of QA/RA KPIs across responsible plants to ensure measured performance improvements based on root cause analysis and defining/ deploying appropriate preventive and corrective actions.
- Reviews Quality Agreements for site related agreements in alignment with Global QS and Legal review.
- Responsible for all remediation activities including systematic identification, risk-based prioritization and corrective action.
- Analyzes internal site assessment and audit trends to develop best practice processes.
- Performs other duties as required.
- Minimum Education: Bachelor’s in Science, Engineering or a technical discipline. Master’s degree preferred.
- Minimum Experience: 12 years of experience in Quality Assurance/ Regulatory in a medical device development and manufacturing environment. Minimum of 10 years of management experience in a medical device development and manufacturing environment with multi-site responsibility
Special Skills:- Able to partner effectively with internal and external partners in a proactive, positive and constructive manner.
- Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.
- Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
- Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
- Strong collaboration, communication and leadership skills to effectively and clearly coordinate across Product Category sites with the site QM.
- Experience and expertise applying change management principles and practices to drive successful enterprise transformation
- Demonstrated influencing skills with all levels of key stakeholders during times of transformation and other situations.
- Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals.
- Demonstrated knowledge of U.S and EU regulatory requirements and standards as it relates to pre-market approval, interactions with regulatory bodies, post-market surveillance, risk management and oversight of corrections and removals.
- Experience with advanced statistical methods: SPC, DOE, ANOVA and others. ASQ of equivalent Certified Quality Engineer, Certified Six Sigma Black Belt or Certified Quality Manager strongly preferred
- Experience with product development, design verification, validation, risk management.
- Has effectively managed large workflow and multiple projects at one time.
- Strong ability for reasoning and logical deduction and to transfer between abstract and concrete concepts.
- Expertise in structured problem solving.
U.S. Applicants: EOE/AA Disability/Veteran - 6 Days Ago
Director, Legal and Regulatory Affairs
- NYSERDA
-
New York, NY
FULL_TIME
- This position is at the NY Green Bank, a division of NYSERDA. NY Green Bank is a globally recognized sustainable investment fund. Its mission is to accelerate clean energy deployment in New York State...
- 9 Days Ago
Director, Regulatory Affairs
- Scismic
-
New York, NY
FULL_TIME
- Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level pr...
- 1 Day Ago
Associate Director Regulatory Affairs
- Discover International
-
Florida, NY
FULL_TIME
- A biopharmaceutical company is dedicated to creating products for immunodeficient patients at risk for infection.If you're looking for a dynamic, innovative, and growing company in the biopharmaceutic...
- 1 Day Ago
Regulatory Affairs Executive Director
- DK06 (FCRS = DK006) Novartis Healthcare A/S
-
Copenhagen, NY
FULL_TIME
- Job Description Summary -Provides strategic direction to teams to achieve registration and drives preparation and submission of regulatory documentation. Interacts and negotiates with regulatory agenc...
- 13 Days Ago
Clinical & Regulatory Affairs, Director
- Meditrial
-
New York, NY
FULL_TIME
- This position serves as a key member of the Meditrial leadership team, providing strategic direction to the Regulatory & Clinical Affairs teams, and is responsible for the development and execution of...
- 16 Days Ago
Regulatory Affairs Director jobs at Popular Companies
Head of Regulatory Affairs
- Exegenesis Bio Inc
-
Ambler, PA
- Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
- 6/11/2024 12:00:00 AM
Head of Regulatory Affairs
- EPM Scientific
-
- Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
- 6/10/2024 12:00:00 AM
Director of Regulatory Affairs
- Verano
-
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/10/2024 12:00:00 AM
Head of Regulatory Affairs
- Hiring Now!
-
West Hills, CA
- HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
- 6/8/2024 12:00:00 AM
Director of Regulatory Affairs
- Catalyst Life Sciences
-
- Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
- 6/8/2024 12:00:00 AM
Head of Regulatory Affairs
- Kaye/Bassman International
-
San Diego, CA
- Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
- 6/7/2024 12:00:00 AM
Sr. Director of Regulatory Affairs - Oncology
- Mantell Associates
-
Boston, MA
- Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
- 6/7/2024 12:00:00 AM
Director of Regulatory Affairs
- Verano
-
Chicago, IL
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/7/2024 12:00:00 AM
About New York
New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States.
New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean.
In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$181,110 to $257,947
Most Popular Cities in New York for Regulatory Affairs Director Jobs
What does a Regulatory Affairs Director do?
Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019