On-Site Specialist, Quality And Regulatory Affairs

• Operates at the QA/RA staff level to execute and assure that all regulatory licenses, registrations, certifications, and submissions are made on time with appropriate content and funding. Provides “lead and direct” oversight of contract Regulatory Affairs consultants. Defines the Regulatory Affairs quality system by authoring documents including system procedures, work instructions, and forms. Provides expert RA input to requests regarding new markets or new regulatory requirements.

Duties and Responsibilities:

• Timely payment of all regulatory fees for licenses, site registrations, and certifications.
• Creation of, content review, payment, and submission of regulatory submissions.
• Completes and submits regulatory submission documents such as US FDA 510(k)s and EU Technical Files, works with reviewing bodies to complete the approval process resulting in opening the targeted market.
• Interact with the regulatory bodies of identified countries to secure “permission to import for sale” types of registrations for IMI products in their country. Maintain these registrations annually or as needed to maintain market availability.
• Oversight and functional subject matter expert for top-level QMS, such as document control, quality system.
• Provides training for the regulatory QMS documentation as needed for IMI employees, contract employees, or outside resources.
• Reviews and approves assigned documents that impact the regulatory footprint of IMI, including but not limited to labels, reports, and advertising.
• Completes required reviews and reports to maintain a compliant regulatory footprint of IMI, which includes but is not limited to risk analysis reviews, post-market surveillance, and technical files for aggregate change impact.
• Supervises contract workers such as Regulatory Affairs consultants, quality systems consultants, or project assistance contractors.

Required Qualifications:

• 3 years’ experience as a Regulatory Affairs professional for medical devices sold within the US.
• Must be able to read, write, and speak the English language and be understood.
• Strong communication skills.
• Able to work independently with limited supervision.
• In-depth knowledge of ISO 13485 and 21 CFR Part 820.
• In-depth knowledge of Regulatory Affairs registration and maintenance programs in US (MDD 93/42/EEC ) and EU (MDR) .
• Strong working knowledge of the websites and contact methods for the US FDA, Health Canada, Australia, and the EU.
• Familiar with the workings and responsibilities of the Notified Body, Authorized Representative, and Competent Authority in the EU and MDSAP countries.
• Working knowledge of the MDSAP program, MDSAP Audits, and its relationship to Competent Authorities.
• RAPS University certificate or equivalent – medical devices/pharma or RAC Certification.
• Working knowledge of registrations and maintenance in some or all the MDSAP countries: USA FDA, Health Canada SOR 292, Brazil (ANVISA), Australia TG(MD)R, and Japan (JPAL).
• Strong working knowledge of the websites and contact methods for the US FDA, Health Canada, and the EU.
• RAPS Accreditation
• RAC Regulatory Affairs Professional.

Preferred Qualifications:

• 5 Years of experience in medical device or pharmaceutical Quality Management Systems.
• Knowledge and experience in Internal QMS audit program and auditing.

Physical/Mental Demands:

• Must sit for long periods of time in an office chair.
• Minimal lifting, up to 50 lbs.
• Normal office environment, subject to heat, cold, or weather for short periods when visiting sites or suppliers.