PRIMARY FUNCTIONS
The primary functions include developing, managing and implementing Regulatory and QA strategies for new products to obtain rapid regulatory approval of submissions in all countries; developing QA/RA professionals and providing QA/RA leadership to multiple new product development sites. Must have previous hands-on experience with regulatory submissions for Italy market and for the foreign markets.
Regulatory Affairs and ISO Management Representative designee for multiple new product development sites. Also responsible for the improvement, efficiency, and effectiveness of the new product development business unit's Quality Management System.
MAJOR RESPONSIBILITIES
• Develops regulatory submission strategies to expedite licensing and registration of new products both domestically and internationally. Prepares submissions for regulatory agencies that get products rapidly approved and cleared to market.
• Ensures design controls processes are compliant to applicable external regulatory requirements (e.g. 93/42/CEE, 21 CFR 820, ISO14971, ISO13485, etc.), while meeting customer expectations, business needs and objectives.
• Drives QMS alignment across multiple new product development sites.
• Regulatory Affairs and ISO Management Representative designee for new product development business unit sites.
• Maintains product approvals and completes all necessary notifications, supplements, amendments, listings and yearly reports required for products on a worldwide basis, including Technical File maintenance.
• Develops and implements RA strategy, including V&V (Verification&Validation) and clinical trials as applicable, for product development and design changes. This may include counseling new product development project team leaders as to product design, and required field and in-house studies to support regulatory strategies, etc.
• Establishes QA/RA team, develops QA/RA professionals and QA/RA competency of Company.
• Experienced interfacing with government regulatory agencies for the discussion of adverse events, general questions or approval of product.
• Monitors activities of government regulatory agencies on a worldwide basis to ensure Company is able to align, support, and anticipate changing regulations.
• Develop a strong working relationship with Company's manufacturing business units to ensure robust design transfer processes.
• Controls and provides corrective action procedures to eliminate scrap and improve
Categoria Professionale: Ingegneria Impiantistica
Settore: INDUSTRIA METALMECCANICA
Città: Granarolo Dell'emilia (Bologna)
Esperienza lavorativa:
Istruzione:
Conoscenze linguistiche:
Patenti:
Mezzi di trasporto:
Disponibilità oraria:
Candidati per questo lavoro →
The primary functions include developing, managing and implementing Regulatory and QA strategies for new products to obtain rapid regulatory approval of submissions in all countries; developing QA/RA professionals and providing QA/RA leadership to multiple new product development sites. Must have previous hands-on experience with regulatory submissions for Italy market and for the foreign markets.
Regulatory Affairs and ISO Management Representative designee for multiple new product development sites. Also responsible for the improvement, efficiency, and effectiveness of the new product development business unit's Quality Management System.
MAJOR RESPONSIBILITIES
• Develops regulatory submission strategies to expedite licensing and registration of new products both domestically and internationally. Prepares submissions for regulatory agencies that get products rapidly approved and cleared to market.
• Ensures design controls processes are compliant to applicable external regulatory requirements (e.g. 93/42/CEE, 21 CFR 820, ISO14971, ISO13485, etc.), while meeting customer expectations, business needs and objectives.
• Drives QMS alignment across multiple new product development sites.
• Regulatory Affairs and ISO Management Representative designee for new product development business unit sites.
• Maintains product approvals and completes all necessary notifications, supplements, amendments, listings and yearly reports required for products on a worldwide basis, including Technical File maintenance.
• Develops and implements RA strategy, including V&V (Verification&Validation) and clinical trials as applicable, for product development and design changes. This may include counseling new product development project team leaders as to product design, and required field and in-house studies to support regulatory strategies, etc.
• Establishes QA/RA team, develops QA/RA professionals and QA/RA competency of Company.
• Experienced interfacing with government regulatory agencies for the discussion of adverse events, general questions or approval of product.
• Monitors activities of government regulatory agencies on a worldwide basis to ensure Company is able to align, support, and anticipate changing regulations.
• Develop a strong working relationship with Company's manufacturing business units to ensure robust design transfer processes.
• Controls and provides corrective action procedures to eliminate scrap and improve
Categoria Professionale: Ingegneria Impiantistica
Settore: INDUSTRIA METALMECCANICA
Città: Granarolo Dell'emilia (Bologna)
Esperienza lavorativa:
- Quality Assurance Manager settore farmaceutico - Settore industriale: SANITARIO/BIOMEDICALE
Istruzione:
- Laurea Magistrale - Matematico / Scientifico
Conoscenze linguistiche:
- Inglese
- Parlato: Ottimo
- Scritto: Ottimo
- Comprensione: Ottimo
Patenti:
- B
Mezzi di trasporto:
- Auto
Disponibilità oraria:
- Full Time
