The Company is a small public company based in Boca Raton, operating in two divisions. Medical Devices: Surgical device marketed in the US, Europe and a range of other countries internationally. The division has ISO 13485 and MDSAP, FDA 510(k) clearance (Class II), CE Mark (Class III, MDD) and other regulatory approvals internationally. Medical Therapies: vision therapies (software) with FDA 510(k) clearance or exemption marketed in the US and with CE Mark (Class I) marketed in Europe from Boca and with a European partner.

The Company handles responsibility for US, EU, Canada and ISO/MDSAP itself. In other international markets it generally appoints its local distributor to be its authorized representative, responsible for regulatory affairs

The Company is seeking a Regulatory Affairs and Quality Affairs person to be responsible for all aspects of the Company’s regulatory matters, reporting directly to the CFO (who has overall Regulatory responsibility), the President (who has responsibility for Quality and manufacturing) and the CEO. This primarily involves the US (FDA), EU (CE Mark) and ISO/MDSAP, so working knowledge of FDA, European regulatory affairs and requirements and ISO/MDSAP is preferred.

Responsibilities include:

· Overall responsibility for the company’s compliance with relevant FDA, CE Mark, ISO and MDSAP requirements.

· Overall responsibility for maintaining all regulatory documentation and records, including device databases (GUDID, Eudamed, etc.).

· Supporting other international authorized representatives with regulatory requests and filings.

· Handling internal and external audits together with the CFO.

· Handling day-to-day QA/RA matters such as customer complaints, CAPAs etc., product incoming inspections, maintenance of records.

· Continual review and refinement of the Quality Management System (QMS), SOPs etc., and ensuring they are applied and followed.

· Handling the regulatory aspects of new and existing product development, in conjuction with outside consultants.

· Conducting and documenting Management Reviews and other required regular updates/reviews. Managing annual key supplier assessments. Coordinating post-market surveillance activities.

· Responsible for ensuring staff training in regulatory matters is kept up to date.

Job Requirements

· In office role, 8.30am to 5.30pm.

· Candidates seeking a fixed part-time role (less than 40 hours/week) will be considered.

· Bachelor’s Degree.

· Min 1-3 years experience in medical device regulatory/quality affairs required.

· Excellent organizational, research, verbal and written skills, be detail-oriented and able to multi-task effectively and meet deadlines.

Job Type: Full-time

Pay: $55,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Work Location: In person