Regulatory Affairs Specialist - Medical Device experience REQUIRED

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Salary: $90,000 - $115,000 per year

An international medical device company is looking to add a Regulatory Affairs Specialist to their USA headquarters!

• 100% Employer paid Med, Dental, Vision
• 4% match on 401K
• 10 paid holidays and 3 weeks PTO to start, goes to 4 weeks after 1 year of employment

This role will be primarily ONSITE in Fort Mill, SC right outside of Charlotte, NC. The client is open to relocation! Please DO NOT APPLY if you are not local and OK with onsite work OR not willing to relocate.

Primary Responsibilities:

• Work with others on the QA/RA team on quality and regulatory issues due to customer complaints.
• Work on trending of products reported deficient.
• Cooperate together with Global Regulatory Office for regulatory compliance according FDA guidelines and 21 CFR 820 and further applicable chapters.

Responsibilities:

• Manage the customer complaints process for North America ensuring that all documentation is completed correctly by relevant personnel.
• Work with quality/service teams to collate product fault trend information.
• Assist in the preparation of reports for the bi-monthly quality meetings
• Strong knowledge and experience in understanding EU MDR, 21 CFR 820, and other regulatory bodies with focus on FDA.
• Understanding of IEC62304, ISO14971, IEC62366, ISO13485, and other relevant standards
• Ability to multitask and prioritize projects that align with departmental and organizational objectives.
• Working knowledge of domestic and international regulations, standards, and guidance documents.
• Strong writing, verbal and interpersonal communication skills.
• Minimum of five years of experience in Regulatory Affairs in the medical device industry.
• Minimum one year of active experience applying design controls. Training in Quality Systems, including QSRs and GMPs for medical devices and ISO standards preferred.
• Experience in reviewing and approving technical documentation.

Education:

Bachelors Degree in Engineering, Biological or Physical Sciences

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