Regulatory Affairs Specialist I

Job Responsibilities and Essential Duties:

• Collect information and documentation for routine submissions to regulatory agencies.
• Seeks out related documentation as required to request agency approvals or in response to agency requests.
• Communicate application progress to internal stakeholders.
• Collaborate with worldwide colleagues regarding product registration, license renewals and updates.
• Maintain regulatory files and tracking databases as required.
• Tracks through review process to ensure timely submission.
• Support with Field Correction and Recall activities.
• Participate in and support internal and third-party audits.
• Supports with the documentation and activities related to EU MDR, PMA, and 510(k) submissions when required.
• Communicate with regulatory agencies as needed.
• Contributes to team effort by accomplishing related duties as requested.
• Assists in special projects as needed.

Required Knowledge, Skills and Abilities:

• Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
• Ability to represent Regulatory Affairs to other departments.
• Working knowledge of principle compliance focused ISO Standards and the use of ISO Standards as special controls.

Minimum Requirements:

• Bachelor's Degree in Scientific/Engineering discipline or equivalent work experience in a regulated industry.
• Understands the requirements of FDA 21CFR Part 820 QMSR, EU MDR, MDSAP, CMDR and ISO 13485.
• Proficient computer skills, including Adobe Professional and MS Office applications (Word/Excel) are required.

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Duties are performed in an office environment or remotely (work from home). May work extended hours during peak business cycles.
• Physical requirements such as lifting a specified weight on a regular basis, standing for a period of time.
• Some traveling may be required

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Targeted salary range: $75,280.00- $94,100.00, depending upon experience and location + 4% bonus target