[Hiring] Regulatory Affairs Specialist @InSync

Role Description

Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.

• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements, and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
• Manage/lead regulatory-driven projects, as directed by management.
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices, and medical terminology.
• Plan, lead, and support internal and Regulatory agency audits.
• Lead and direct engagement with regulatory authorities as required.
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
• Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Review product labeling to ensure compliance with regulatory requirements.
• Other activities as assigned.

Qualifications

• Preferably with EU MDR submission experience.
• 510(k) experience is not required but would be an added bonus.

Requirements

• Pay rate: $35.71 - $39.28/hr
• Hours: 8-5pm
• Location: Cordova, TN - Memphis preferred, open to remote candidates (please specify location/time zone on resume)
• Duration: 2 years

Benefits

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

Company Description

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.