Regulatory Affairs Specialist II

Job description

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.

JOB DESCRIPTION:

This regulatory position will have primary responsibility for US, EU and Canada submissions for surgical tissue heart valves. This includes various PMA supplements, EU submission for MDD and MDR requirements and Health Canada submissions. The product lines are established surgical heart valves with minor changes to support manufacturing or incremental design changes.

The ideal candidate will have some US, EU and Health Canada submission experience and be self-directed in working with internal and external customers to new products and support product renewals in these markets. As requests are received from various international geographies, the specialist will prepare, review and coordinate project submissions for regulatory approvals. As experience is gained in international submissions, opportunity to support US, EU, and Canada on pre-market will also be included.

Duties:

• Prepare product submissions for US/EU/CA markets
• Prepare appropriate documentation for US/CA annual reports
• Develop regulatory strategies for implementation of product changes (working with international counterparts)
• Communicate and coordinate regulatory activities with other departments
• Review product and manufacturing changes for compliance with applicable regulations (Change Control)
• Manage product approval records and prepare product release documentation per department procedures
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Performs other related duties and responsibilities, on occasion, as assigned

Preferred Experience:

• BA or BS degree; technical discipline preferred
• 0-2 years medical device regulatory experience
• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions
• Working knowledge of EU medical device regulations

• 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
• Ability to travel approximately 5%, including internationally
• Ability to maintain regular and predictable attendance
• 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

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