Person2Person, LLC
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| Director RA/QA Based in NY |
| Outstanding growth opportunity with an Importer and Distributor of Class I and Class II Medical Devices and OTC Pharmaceuticals. Be a part of this exciting growing Company! Reporting to the COO, manages QA /RA department of 6-8. Responsibilities also include; the oversight of RA, QA and all quality systems, as well as being an integral part of the NPD team, the direction of all regulatory affairs including regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, and Canadian Medical Device Regulations. |
| SCOPE & DUTIES |
• The development in designing and enhancing regulatory initiatives to facilitate overall regulatory
compliance, perpetration of 510(k) Premarket Notifications, and submissions.
• Oversight of 21 CFR 820
• Preparation of responses to Regulatory authorities, supplements, and amendments; participation
in final company document review and corrections; preparation of additional information as needed.
• Ensures the familiarity by all member of team with correct formats/procedures for labeling as well
as monitors labeling regulations, external environment and proposed US regulations/guidance.
• Provides regulatory oversight of changes in manufacturing facilities, processes, procedures, and
testing methods.
• Directs internal and external compliance programs, audits and site inspections by federal and
international regulatory agencies. Writes and updates departmental Standard Operating Procedures.
• Provides regulatory input to ensure activities are in compliance with all appropriate regulations
and standards, including FDA, ISO 13485:2003, and CMDR.
• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant
regulatory authorities that may impact the company and presents information as needed.
• Maintains professional and technical knowledge by attending educational workshops, establishing
personal networks and participating in professional societies. Performs all other related duties as
directed by supervisor.
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket
Notifications, Premarket Approval Applications, (PMAs), New Drug Applications (NDA). Must possess and
demonstrate an excellent understanding of FDA, International ISO Standards, Medical Device Directives
(93/42EEC), Canadian Medical Device Regulations. Proficient use of Microsoft Office, Word, Excel,
PowerPoint. Must be project oriented requiring minimal supervision. Must have strong writing, project
management and communication skills
compliance, perpetration of 510(k) Premarket Notifications, and submissions.
• Oversight of 21 CFR 820
• Preparation of responses to Regulatory authorities, supplements, and amendments; participation
in final company document review and corrections; preparation of additional information as needed.
• Ensures the familiarity by all member of team with correct formats/procedures for labeling as well
as monitors labeling regulations, external environment and proposed US regulations/guidance.
• Provides regulatory oversight of changes in manufacturing facilities, processes, procedures, and
testing methods.
• Directs internal and external compliance programs, audits and site inspections by federal and
international regulatory agencies. Writes and updates departmental Standard Operating Procedures.
• Provides regulatory input to ensure activities are in compliance with all appropriate regulations
and standards, including FDA, ISO 13485:2003, and CMDR.
• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant
regulatory authorities that may impact the company and presents information as needed.
• Maintains professional and technical knowledge by attending educational workshops, establishing
personal networks and participating in professional societies. Performs all other related duties as
directed by supervisor.
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket
Notifications, Premarket Approval Applications, (PMAs), New Drug Applications (NDA). Must possess and
demonstrate an excellent understanding of FDA, International ISO Standards, Medical Device Directives
(93/42EEC), Canadian Medical Device Regulations. Proficient use of Microsoft Office, Word, Excel,
PowerPoint. Must be project oriented requiring minimal supervision. Must have strong writing, project
management and communication skills
| REQUIREMENTS |
BS with 5-10 years experience in OTC, Pharma or Medical Device.
• Must have proven track record with minimum 5 years team management experience and possess
true leadership abilities
• Must possess excellent interpersonal leadership skills
• Experience in 510K preparation and submission
• Familiar with OTC pharm registration and submission
• Experience with FDA, FDA QSR, GMP’s, and drug cGMP
• Familiar with ISO 13485 and CMDCAS and Canadian Submissions
• Experience in USFDA and ISO auditing
• Full knowledge of 21 CFR 820
• Must have proven track record with minimum 5 years team management experience and possess
true leadership abilities
• Must possess excellent interpersonal leadership skills
• Experience in 510K preparation and submission
• Familiar with OTC pharm registration and submission
• Experience with FDA, FDA QSR, GMP’s, and drug cGMP
• Familiar with ISO 13485 and CMDCAS and Canadian Submissions
• Experience in USFDA and ISO auditing
• Full knowledge of 21 CFR 820
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |