Manager Regulatory Affairs
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Job Location:
Lake Forest, CA - USA
Monthly Salary:
$ 99300 - 198700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our Lake Forest IL location in the Diagnostics division.
Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.
As the Manager Regulatory Affairs the main responsibility of this role is to combine knowledge of scientific regulatory and business issues to enable products that are developed manufactured or distributed to meet required regulations. The incumbent will ensure that the business complies with current standards regulations and industry requirements and will represent CMI RA during audits.
The Opportunity
Regulatory Strategy & Submissions
- Develop and implement regulatory strategies to support product development and commercialization. Oversee preparation and submission of product registrations progress reports supplements amendments and periodic reports. Experience with US FDA and IVDR are a plus.
Leadership & Team Management
- Manage and mentor regulatory staff fostering a collaborative and high-performing team. Provide regulatory guidance and support to cross-functional teams.
Compliance & Culture
- Promote a commercially aware compliance culture. Ensure adherence to harmonized standards and evolving regulations while balancing business objectives.
Regulatory Representation
- Act as delegate for Management Review when required. Serve as the primary regulatory liaison throughout the product lifecycle including interactions with regulatory agencies to expedite approvals.
Product Development & Risk Management
- Participate in product planning regulatory strategy development and risk management activities. Provide expert advice on manufacturing changes line extensions technical labeling and regulatory interpretations.
Change Control & Lifecycle Management
- Oversee regulatory aspects of the change control process. Ensure timely and compliant execution of product changes.
Advertising & Promotion Compliance
- Lead the Advertising and Promotional Review function within Regulatory Affairs. Collaborate with Commercial and Marketing teams to ensure compliant promotional materials.
Unique Device Identification (UDI)
- Implement and manage UDI requirements across applicable products.
Field Actions & Audits
- Support field action reporting activities as needed. Represent Regulatory Affairs during internal and external audits.
Regulatory Intelligence & Problem-Solving
- Proactively analyze regulatory feedback identify challenges and develop solutions to facilitate approvals and maintain compliance.
Required Qualifications
- Bachelors degree in Science Math Engineering or medical fields.
- Minimum 5 years in a regulated industry (e.g. medical products in vitro diagnostics). Regulatory experience preferred but may consider quality assurance research and development scientific affairs operations or related area.
- Up to 15% travel required.
Preferred Qualifications
- Masters degree in technical area or MBA.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United States > Lake Forest : J55
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 15 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
