Acero Precision is a leading, global OEM Contract Manufacturer of precision machined components. We specialize in the manufacturing and assembly of complex, close tolerance products. Our range of clients include the Medical Device, Motorsport, and Analytical Industries. At Acero Precision we are building a brand new state-of-the-art 80,000 square foot manufacturing facility located in West Chester, PA, a suburb of Philadelphia.
In order to maintain our growth and continue serving our customers with excellent service, our Recruiting Team searches for the best and brightest in their field. We are seeking a Manager of Regulatory Affairs with medical products expertise in domestic and international regulatory activities associated with the FDA, ISO, and international regulations.
Daily operations include, but are not limited to:
Completes and writes submission documents for product approvals for the US FDA.
Involvement in the preparation of FDA 510(k), IDE, PMA and PMA Supplement submissions.
Assist Quality Assurance in the resolution of supplier quality issues, determination of cause and corrective actions and the update of material specifications as necessary .
Involvement in the preparation of international submissions.
Complete reviews of labels, literature and Web site for accuracy, consistency and regulatory compliance.
Develop and/or revise regulatory policies and procedures.
Prepare annual reports for PMA devices.
Review new product design protocols related to verification, validation, FMEA, etc.
Maintain SOP documentation.
Process ECOs and CAPAs.
Develop QA sampling plans; create QA reports.
Develop equipment validation protocols.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. The candidate should be capable of working in a team oriented environment and dealing with all levels of employees.
Bachelor's Degree, preferably in the physical sciences or legal areas
Five years direct experience in Regulatory Affairs or Five years experience in Clinical Affairs or Quality Assurance within the Medical Device Industry
(FDA and ISO)
Solid working knowledge of the regulatory requirements additional experience with international registration requirements highly desirable
Experience with (US) class I, II and III medical devices
Capacity to communicate regulations to technical functions within the company
Ability to manage relationships with FDA and international "customers" (e.g., regulatory agencies, distributors, etc.)
Understanding of sterility processes (Gamma, ETO)
Working knowledge of statistics
Solid computer skills, especially with Microsoft Excel, and Microsoft Access and/or SQL
Willing to work 50 or more hours weekly, and potentially two Staurdays per month.
Certifications and/or specialized training.
Principals only. Recruiters please do not reply to Acero job posts. All applications and/or contact information submitted are kept on file and are the property of Acero Precision.
Please Note: This position is located in Newtown Square, PA. Partial relocation expenses are covered for the right candidate
Keyword: Regulatory, Quality Assurance, FDA 510(K), IDE, PMA, ISO, Manager
From: Acero Precision
Acero Precision - 10 months ago
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