Regulatory Affairs Specialist at Safeguard Medical (International)

Huntersville, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Sep, 26

Salary

0.0

Posted On

03 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Medical Device Regulations, FDA Compliance, EU MDR, ISO 10993, Technical File Management, Labeling Review, GUDID Database, Post Market Compliance, Regulatory Submissions, Change Order Assessment, Global Regulatory Affairs

Industry

Medical Device

Description

Description The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. Essential Job Functions Review labeling, training, and promotional material Support product and shipping release. Maintenance of FDA’s GUDID database Technical file update and reviews Review of External Standards Support business with government queries and registration documentation requirements. Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions Support post market regulatory compliance activities for US/International product approvals Assist with the development and maintenance of regulatory affairs department procedures Comply with applicable FDA and international regulatory laws/standards Ensure relevant ISO and FDA Export requirements are met, as required Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Compiles all materials to support submissions, license renewal and annual registrations. Keeps abreast of regulatory procedures and changes. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products Customer Service Support Proactively drive activities to meet and/or exceed company objectives. Maintain regulatory files/database and chronologies in good order. Manage interactions with distributors, consultants, and/or partners. Perform other related duties and responsibilities as assigned. Requirements Qualifications Bachelor’s Degree required At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience Solid working knowledge of relevant domestic and global regulations and guidance Exercise outstanding judgment in all areas of responsibility. History of successful interactions with global regulatory authorities Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. A combination of education and experience may be considered Competencies Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry. Knowledge of FDA, MDD, EU MDR Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility). RAC certification is a plus. Ability to focus and achieve scheduled milestones, including contingency planning. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Physical Requirements Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code. Mental Requirements This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions. Other Requirements Some travel, approximately 15% Work Environment The noise level in the work environment is usually quiet to moderate. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.

Responsibilities

The specialist manages the registration and life-cycle of medical products by executing regulatory strategies and ensuring compliance with FDA and international standards. Key duties include reviewing labeling, maintaining technical files, and coordinating document packages for regulatory submissions.