Regulatory Specialist I conducting regulatory activities for health care facilities across Florida. Prepares reports, manages files and provides support for QA reviews in the agency.
About the role
- Regulatory Affairs position involving three 1-year rotations at Abbott Medical Device in the U.S. Ensuring compliance and supporting regulatory activities in medical device registration.
Responsibilities
- 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.
Requirements
- 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.
- BA or BS degree in life sciences (i.e., chemistry, biology, etc.) or engineering (i.e., biomedical, mechanical, chemical, etc.) preferred.
- Some experience with medical device industry.
- Experience working in a broader enterprise/cross-division business unit model.
Benefits
- 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 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 bachelor’s 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.
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