Specialist Regulatory Affairs - AMD

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Specialist

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

At Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Abbott Molecular has an opening in its Des Plaines, IL site for a Regulatory Affairs Specialist.

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

WHAT YOU'LL DO:

Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives

Creates, reviews, and approves engineering changes.

Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.

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, if requested.

Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.

May interface directly with FDA and other regulatory agencies if so directed.

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) 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 vendor

Other Job Requirements:

Supports software verification and validation activities by review and approval of software test cases.

Supports non-product software validation by reviewing protocols, reports and other documentation as required.

Supports review of other software design documentation as needed, such as development plans, change assessment plans, requirements, verification and validation summaries, and risk management documentation.

Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, and processes.

Maintains a strong, collaborative partnership with cross functional team members.

Works as an individual contributor and may provide guidance or oversee work of other team members.

Performs other related duties and responsibilities, on occasion, as assigned.

Education / Skills / Experience:

Required:
  • Bachelor's Degree, Technical discipline preferred, an equivalent combination of education and work experience
  • Experience working in a broader enterprise/cross-division business unit model preferred. 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.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Preferred:

Some experience with medical device industry preferred.

WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

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