Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
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$ 79500 - 138700
1 Vacancy
Job Description
JOB DESCRIPTION:
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and 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 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 around the world 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 a best place to work for diversity working mothers female executives and scientists
This Regulatory Affairs Specialist II will work on-site at our Santa Clara CA or Woodridge MN location in our Abbott Ventures division to perform regulatory activities for a transcatheter heart valve replacement device.
The Opportunity
As an individual contributor this position performs specialized level work assignments and/or analyses evaluation preparation and submission of documentation for regulatory approval ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry.
What Youll Work On
- Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
- Creates reviews and approves engineering changes.
- Reviews and provides input on device labeling.
- Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements especially those that are new or modified are distributed to appropriate personnel.
- May interface directly with FDA and other regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
Required Qualifications
- Bachelors Degree or an equivalent combination of education and work experience
- Minimum 3 years related experience including a minimum of two years regulatory experience
- Experience with either 510(k) applications IDE supplements PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
- Ability to work within a team and as an individual contributor in a fast-paced changing environment. Ability to leverage manage and/or engage others to accomplish projects.
- Strong problem-solving skills and ability to think strategically and see the big picture.
- Adaptable with the ability to switch priorities and accomplish all tasks.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills as well as attention to detail.
- Multitasks prioritizes and meets deadlines in timely manner.
Preferred Qualifications
- Bachelors Degree in a Science/Technical discipline (engineering life sciences mathematics).
- Masters degree
- Experience with regulatory activities required for clinical trials.
- Experience working in a broader enterprise/cross-division business unit model.
- Experience working in the Medical Device industry.
- Regulatory Affairs Professionals Society Certification is a plus.
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.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$79500.00 $138700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
SH Structural Heart
LOCATION:
United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS:
United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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