Defibtech Senior Regulatory Affairs Specialist
Defibtech is seeking a Senior Regulatory Affairs Specialist responsible for facilitating and supporting various regulatory activities reporting to our Senior Director of Regulatory Affairs. This position is based at our headquarters in Guilford, CT with consideration for a partial remote work schedule.
• Facilitates and supports regulatory-based projects as an active project team member with assistance from Regulatory Affairs Senior Director.
• Previews and reviews change notices to assess regulatory status impact.
• Reviews documentation required to support various regulatory activities.
• Assists with regulatory approval application preparation and submission process.
• Reviews labeling and promotional materials to ensure compliance with FDA, European Union and other international requirements.
• Assists with FDA customs import/export requests, customer service needs, and other requests from internal or external customers.
Initiates and updates technical files/registrations as necessary.
• Demonstrates Defibtech’s values on the job by focusing actions on Integrity, Passion, Ownership, and Innovation. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).
• Bachelor’s degree or equivalent work experience
• At least 5 - 7 years regulatory affairs experience in the medical device industry
• Experience working with health ministries and agencies throughout the world, including FDA and European Union
• In-depth knowledge of medical device regulations
• Experience implementing regulations into Quality Systems
• Regulatory Affairs Professional Society (RAPS) certification preferred
Work Environment and Physical Demands:
• Work environment is primarily based in an office setting.
• Physical demands are primarily sedentary with frequent sitting, standing and short durations of walking throughout location(s) and lifting up to 10lbs.
Compensation and Benefits:
• Defibtech offers competitive salaries and a comprehensive benefits package including core health benefits, company-paid disability, and a company matching 401k plan.
• Defibtech promotes a challenging, collaborative and friendly culture that is centered around our values: Passion, Innovation, Integrity and Ownership.
• Defibtech is supportive of work balance providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.
• Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.
Defibtech is committed to a diverse workplace and is an Equal Opportunity/Affirmative Action employer and E-Verify Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
The above description of core responsibilities and qualifications are intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Defibtech endeavors to make www.defibtech.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.
To Apply Click Here:https://www.defibtech.com/careers