JOB TYPE: Temp
HOURLY RATE: Commensurate with experience
JOB DESCRIPTION:
Participate in developing regulatory strategies for approval of products and new intended uses globally and coordinate in the preparation of regulatory submission documentation. Assures the company’s compliance with the regulations and promotes a strong working relationship with agencies and organizations that govern company products.
KEY RESPONSIBILITIES:
• Coordinate in the development and modification of regulatory processes and templates; when applicable conduct training on regulatory processes.
• Collaborates with company Global and Regional Product Management, regional Regulatory/Quality team members and other internal stakeholders to assist in establishing global regulatory marketing approval strategies in support of new and existing products.
• Assists in the preparation of documentation for submissions for new product or new intended uses for existing products in support of domestic and international product marketing approvals.
• Assists in establishing global regulatory strategies to obtain the appropriate regulatory clearances/approvals for existing products in terms of modifications to intended use, design, labelling, materials, and manufacturing processes.
• Prepares, coordinates, reviews, and archives regulatory submissions and registration dossiers.
• Assist in various projects as assigned.
REQUIREMENTS:
• Must have medical device or pharma regulatory experience
• 3-5 years regulatory experience in the medical device industry and 3-5 years experience in QA/RA.
• Working knowledge of global medical device regulations.
• Ability to work well on cross-functional teams with experience supporting product design and development projects desirable.
• Must be able to render clear and accurate judgments.
• Computer knowledge in Microsoft Word, Excel, Access, etc.
• Proficiency in Access database programming.
• Leadership and organizational skills.
EDUCATION / TRAINING:
• B.A. or B.S. degree
PREFERRED QUALIFICATIONS:
US, Europe and Canada Regulatory Affairs Certification (RAC) a plus.
EQUAL OPPORTUNITY EMPLOYER
PLEASE SEND RESUME IN MS WORD FORMAT
Keywords:
Regulatory Affairs Certification, rac, qa, ra, regulatory affairs, global regulatory, regulatory affairs specialist, global, regional, medical device, fda, iso, ul, quality, access database, global medical device regulation
HOURLY RATE: Commensurate with experience
JOB DESCRIPTION:
Participate in developing regulatory strategies for approval of products and new intended uses globally and coordinate in the preparation of regulatory submission documentation. Assures the company’s compliance with the regulations and promotes a strong working relationship with agencies and organizations that govern company products.
KEY RESPONSIBILITIES:
• Coordinate in the development and modification of regulatory processes and templates; when applicable conduct training on regulatory processes.
• Collaborates with company Global and Regional Product Management, regional Regulatory/Quality team members and other internal stakeholders to assist in establishing global regulatory marketing approval strategies in support of new and existing products.
• Assists in the preparation of documentation for submissions for new product or new intended uses for existing products in support of domestic and international product marketing approvals.
• Assists in establishing global regulatory strategies to obtain the appropriate regulatory clearances/approvals for existing products in terms of modifications to intended use, design, labelling, materials, and manufacturing processes.
• Prepares, coordinates, reviews, and archives regulatory submissions and registration dossiers.
• Assist in various projects as assigned.
REQUIREMENTS:
• Must have medical device or pharma regulatory experience
• 3-5 years regulatory experience in the medical device industry and 3-5 years experience in QA/RA.
• Working knowledge of global medical device regulations.
• Ability to work well on cross-functional teams with experience supporting product design and development projects desirable.
• Must be able to render clear and accurate judgments.
• Computer knowledge in Microsoft Word, Excel, Access, etc.
• Proficiency in Access database programming.
• Leadership and organizational skills.
EDUCATION / TRAINING:
• B.A. or B.S. degree
PREFERRED QUALIFICATIONS:
US, Europe and Canada Regulatory Affairs Certification (RAC) a plus.
EQUAL OPPORTUNITY EMPLOYER
PLEASE SEND RESUME IN MS WORD FORMAT
Keywords:
Regulatory Affairs Certification, rac, qa, ra, regulatory affairs, global regulatory, regulatory affairs specialist, global, regional, medical device, fda, iso, ul, quality, access database, global medical device regulation