Sr. Regulatory Affairs Specialist (Defined Term)

Job Overview

Responsible for internal, domestic and international compliance activities. Prepare comprehensive regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management., project teams and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.

Job Responsibilities and Essential Duties

• Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.
• Prepares Regulatory strategy/plans and requirements.
• Prepares documentation and coordinates activities related to EuMDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s and IEDs.
• Prepares worldwide regulatory submissions/registrations including collecting information and documentation for submissions to regulatory agencies.
• Update/maintain basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency.
• Participates in the review and disposition of labeling, promotional material and product modifications.
• Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations.
• Complies and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirement and tracks timeline through review process to ensure timely submission.
• Participates in cross-functional departmental team projects and products development activities/meetings.
• Support with Field Correction and Recall activities
• Responsible for FDA/ISO/MDD/MDR/CMDR compliance documentation
• Participates in and support internal and third-party audits
• Assists in special projects as needed
• Contributes to team effort by accomplishing related duties as requested

Minimum Requirements

• Bachelor's Degree and a minimum four years of directly related experience in Regulatory Affairs in a medical device environment, or a minimum ten years of directly related experience in Regulatory Affairs in a medical device environment.
• Experience wit the preparation, submissions and approval for medical devices is required including 410(k) or PMA.
• Understands the requirements of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR and ISO 13485.
• Proficient computer skills, including MS office applications (Word/Excel) are required.

Required Knowledge, Skills and Abilities

• Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
• Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
• Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills.
• Ability to represent Regulatory Affairs to other departments.
• Working knowledge of principle compliance focused ISO Standards (13485, 14971, 62366) and the use of ISO Standards as special controls.

Supervision/Management Of Others: None

Internal and External Contacts/Relationships

• Maintains effective relationships with internal customers.
• Build relationships and participates as a member of a cross-functional product development team.
• Professionally negotiate/communicate directly with regulatory entities (e.g., governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level.

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
• May work extended hours during peak business cycles