Regulatory Affairs Specialist – Vascular (on-site)

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.

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

We are hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara CA location. As an individual contributor this new team member will combine knowledge of scientific regulatory and business issues to enable products including combination products that are developed manufactured or distributed to meet required legislation. The individual may share knowledge and expertise with others in support of team activities as well as identify data needed obtain this data and ensure that they are effectively presented for the registration of products worldwide.

What Youll Work On

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Provide regulatory input to product lifecycle planning.
• Evaluate proposed preclinical clinical and manufacturing changes for regulatory filing strategies.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Creates reviews and approves engineering changes.
• May interface directly with FDA and other regulatory agencies.
• 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.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• 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 of 2 years experience in a regulated industry (e.g. medical products nutritionals pharma food). 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.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Negotiate internally.
• Pay strong attention to detail.
• Ability to leverage manage and/or engage others to accomplish projects.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.
• Ability to work within a team environment and accomplish projects within a fast-paced matrixed environment.
• Ethical guidelines of the regulatory profession clinical research and regulatory process.

Preferred Qualifications

• Bachelors Degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields
• Masters degree
• Experience with either 510(k) applications PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced changing environment.
• Strong organizational and follow-up skills as well as attention to detail.
• Multitasks prioritizes and meets deadlines in timely manner.
• 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

In specific locations the pay range may vary from the range posted.

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