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. You’ll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with high employer contribution
* Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s 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.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
The Opportunity
Abbott is seeking a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas to ensure regulatory considerations are integrated throughout the product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical device regulations is preferred.
What You’ll Work On
- Evaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities.
- Prepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives.
- Assess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets.
- Develop and document regulatory assessments supporting design control and change management activities.
- Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
- Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
- Support maintenance of regulatory approvals and registrations for commercially marketed products.
- Support the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.
- Support all Company initiatives as identified by 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) regulations, international regulations and 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.
- Performs other related duties and responsibilities as assigned.
Required Qualifications
- Bachelor’s degree (or equivalent)
- 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
- Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Preferred Qualifications
- Bachelor’s degree in science (biology, chemistry, microbiology, etc.), engineering, or biomedical fields.
- Master’s degree in Regulatory Affairs.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Experience within the medical device industry, particularly supporting Class II and/or Class III products.
- Experience supporting commercially marketed medical devices, including post-market compliance and regulatory maintenance activities.
- Experience authoring or supporting regulatory submissions and regulatory strategies that resulted in successful regulatory outcomes.
- Experience with U.S. regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, PMAs, and PMA supplements.
- Experience with EU MDR (2017/745) Technical Documentation and change assessments.
- Working knowledge of medical device regulations and international standards, including ISO 13485, and ISO 14971.
- Experience conducting regulatory assessments associated with design, manufacturing, supplier, labeling, and process changes.
- Experience with risk management activities and documentation in accordance with ISO 14971.
- Experience working within medical device quality systems and design control environments.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, and change control processes.
- Ability to work effectively in a highly matrixed and geographically diverse organization.
- Experience with cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies is preferred.
[Apply Now](https://www.jobs.abbott/us/en)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:[ www.abbottbenefits.com](http://www.abbottbenefits.com/pages/candidate.aspx)
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 [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews.
The base pay for this position is
$81,500.00 – $141,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
AVD Vascular
LOCATION:
United States > Santa Clara : Building B - SC
ADDITIONAL LOCATIONS:
United States > Temecula : Building E - TE
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % 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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
About Us
Abbott is about the power of health. For more than 135 years,
Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of
Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at
Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,
Abbott welcomes and encourages diversity in our workforce.
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