Medical Device Regulatory Affairs Development (RAD) Program
- United States - California - Santa Clara
- United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive
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- 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 107,000 colleagues serve people in more than 160 countries
JOB DESCRIPTION:
- For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
- We currently have multiple opportunities for the Medical Device Regulatory Affairs Development (RAD) Program. This position is included in the Medical Device Regulatory Affairs Development (RAD) Program and performs multiple rotations that include 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. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory business such as the regulatory database and global regulatory SharePoint sites.
- 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.
- 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, on occasion, as assigned.
- EDUCATION AND EXPERIENCE YOU’LL BRING
- Required
- 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.
- Ability to maintain regular and predictable attendance.
- Ability to move to various US locations based on rotational assignment
- Preferred
- BA or BS degree in life sciences (i.e., chemistry, biology, etc.) or engineering (i.e., biomedical, mechanical, chemical, etc.).
- Some experience with medical device industry preferred.
- Experience working in a broader enterprise/cross-division business unit model 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
- Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
- Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.