- Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the medical product.
- Authors and s upports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Declaration of Conformity as applicable. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues.
- Provides regulatory policy, intelligence interpretation and strategy (e.g., Pharma and Medical Device Regulation) for medical products to support global regulatory plans.
- Coordinates across the Allergan Aesthetics portfolio with the regulatory teams of each portfolio to provide consistent strategies for broad regulatory issues such as digital health t echnology and clinical outcome assessments
- Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues.
- Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability.
- Supports and develops global regulatory teams to meet company objectives .
- Bachelors Degree in life sciences or engineering . Relevant advanced degree in a scientific discipline is highly desirable.
- 8 years of regulatory experience in the medical device or pharma industry.
- E xperience with D igital H ealth, Clinical Outcome Measurement preferred.
- Experience in the CE Marking process, global regulatory strategy, and regulatory submission process.
- Proven experience in and ability to manage relationships with regulatory agency personnel.
- Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance.
- Strong knowledge of medical device and pharma regulations
- Ability to travel up to 10% of time
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs.
-
Allergan Aesthetics Irvine, United StatesJob Description · Job DescriptionCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, ...
-
Blank Ast 2
1 week ago
UC Irvine Campus Irvine, United StatesUpdated: Apr 16, 2024 · Location: Irvine-Campus · **Job Type**: · Department: Soc Sci/Undergrad Stud Affairs · **Job Opening ID**:67800 · **Reports To**: Jeanett Castellanos · **Working Title**: BLANK AST 2 · **Department**: Soc Sci/Undergrad Stud Affairs · **Bargaining Unit**: C ...
-
Specialist, Clinical Education Thv, Orange
2 weeks ago
Edwards Lifesciences Irvine, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
-
Group Brand Manager, Critical Care
4 days ago
Edwards Lifesciences Irvine, United StatesJob Description · For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every pat ...
-
Data Analyst, Surgical
1 day ago
Edwards Lifesciences Irvine, United StatesDedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' q ...
-
Regulatory Affairs Specialist, Selution
1 day ago
Cordis Irvine, United StatesOverview: · MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare worldwide. We specialize in the development, manufacturing, and commercialization of cutting-edge coronary and peripheral medica ...
-
In-house Clinical Research Specialist
2 weeks ago
Edwards Lifesciences Irvine, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
-
Rep, Clinical Records
1 day ago
Edwards Lifesciences Irvine, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
-
Clinical Core Labs Analyst
4 days ago
Edwards Lifesciences Irvine, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
-
Principal, Statistical Programming
4 days ago
Edwards Lifesciences Irvine, United StatesJob Description · Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll ...
-
Edwards Lifesciences Irvine, United StatesJob Description · Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offeri ...
-
International Student Advisor I
6 days ago
Westcliff University Irvine, United States: · What if I told you it is possible to find a Company that lived to educate, inspire and empower others while creating a family atmosphere that truly appreciates and respects their team? Would you apply? What if I threw in strong Company values, outstanding benefits, and the op ...
-
Litigation Counsel
1 week ago
Kia America, Inc. Irvine, United StatesAt Kia, we're creating award-winning products and redefining what value means in the automotive industry. It takes a special group of individuals to do what we do, and we do it together. Our culture is fast-paced, collaborative, and innovative. Our people thrive on thinking diffe ...
-
Product Development Associate
1 day ago
iHerb Irvine, United States**Job Summary**: · Under general supervision of the Senior Manager of Product Development, the Product Development Associate provides technical support for various product development and project management functions. This position plays a key role in conducting research, coordin ...
-
Public Affairs Manager
1 week ago
Mesa Water District Costa Mesa, United States**Description**: · - ** · Professional & Technical Expertise** - Experience managing public communications, outreach programs, and communication strategies. · - ** Crisis Management**: · - Ability to effectively navigate the media and public communications during a major threat t ...
-
Executive Assistant
2 weeks ago
MLG Attorneys at Law Costa Mesa, United StatesMLG's Executive Assistant role is a unique blend of responsibilities, combining the traditional duties of an Executive Assistant with the personal support typically associated with a Personal Assistant. As the Executive Assistant, you will play a crucial role in providing compreh ...
-
Project Lead I
8 hours ago
Alcon Lake Forest, United StatesAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. ...
-
Public Affairs Specialist
2 weeks ago
Orange County Sanitation District Fountain Valley, United States**Description**: · - What do **you **value in your next job? · At the **Orange County Sanitation District **our **Core Values **form the framework of our organization and reinforce our professional work ethic. If the following values ring true with you, we'd love to invite you to ...
-
Associate IT Support Technician
1 week ago
Veranex, Inc. Orange, United StatesVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data manag ...
-
Oc Community Resources Staff Specialist
8 hours ago
County of Orange Orange County, CA, United States**CAREER DESCRIPTION**: · **OC COMMUNITY RESOURCES STAFF SPECIALIST** · **(STAFF SPECIALIST)** · **SALARY INFORMATION** · - In addition to performance-based merit increases, this position is scheduled to receive salary range increases on the following dates: · - Effective June 28 ...
Associate Director, Regulatory Affairs Innovation - Irvine, United States - AbbVie
Description
Company Description
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit Follow Allergan Aesthetics on LinkedIn.
Job DescriptionThe Associate Director of Regulatory Innovation supports regulatory objectives for Allergan Aesthetics products including coordination, management of global submissions. Directs and supports development of the regulatory strategy with a focus on Clinical Outcome Assessment (COA) tools including digital and submission activities for device regulatory approvals in a variety of counties including EU, US, Japan, and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan Aesthetics at Regulatory Authority/Notified Body meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all company policies and procedures.
Responsibilities include:
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Associate Director, Regulatory Affairs Innovation professionals in Irvine
-
Josh Miller
Executive Level Leader and Industrial Engineer