Regulatory Affairs Specialist II – Heart Failure (on-site)

The Opportunity

As an individual contributor, this position performs specialized level work assignments and / or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.

This new team member will support necessary regulatory activities required for product market entry.

What You’ll Work On

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• 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.

• May interface directly with FDA and other regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• 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) 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

• Bachelor’s Degree or an equivalent combination of education and work experience
• Minimum 3 years’ related experience, including a minimum of two years 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.
• 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, manage and / or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.
• Multitasks, prioritizes and meets deadlines in timely manner.

Preferred Qualifications

• Bachelor’s Degree in a Science / Technical discipline (engineering, life sciences, mathematics).
• Master’s degree
• Experience working in a broader enterprise / cross-division business unit model.
• Experience working in the Medical Device industry.
• Regulatory Affairs Professionals Society Certification is a plus.
30+ days ago