Regulatory Affairs Specialist (Temporary/Contract)
Location: Braintree Massachusetts
Description: Haemonetics Corp. is hiring Regulatory Affairs Specialist (Temporary/Contract) right now, this job will be placed in Massachusetts. More complete informations about this job opportunity kindly read the description below. HAEMONETICS, THE Blood Management Company is a global leader engaged in the design, manufacture and worldwide sales and marketing of blood mana! gement solutions. Recognized as the innovator in blood technologies, our mission is to create innovative products, design information technology platforms and to provide consulting services to advance the safety, quality and availability of the world’s blood supply.
Regulatory Affairs Specialist (Temporary)
The Regulatory Affairs Specialist compiles and writes submission documents for product approvals for the US FDA and Health Canada. These documents include 510(k) Premarket Notifications, Investigational Device Exemption applications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports. This position works with program teams in identifying regulatory requirements early in the new product development process.
Participates as a member of a product development team to provide regulatory support to the project.
- Proactively partner with R&D, Marketing and ot! her groups to compile appropriate technical documents for regu! latory submissions in support of the development project.
- Accountable to develop and maintain the Technical File for the project â€" with limited guidance and direction.
- Provide training and guidance to product development teams regarding specific product submission requirements.
- Write submission documents for FDA and Health Canada, compile information and write responses to questions from reviewing agencies.
- May participate in conducting training programs to educate employees on regulatory requirements and good regulatory practices in conjunction with Sr. RA Specialist, Director or Sr. Mgr WW Compliance & Training.
- Identify appropriate standards for application in support of product development; present and guide decisions accordingly.
- Review new regulatory guidance and implement programs to ensure compliance or provide recommendation to Compliance & Training on improvements and opportunities.
- Provide input reg! arding product recalls or advisory notices, CAPA investigations, and risk assessments.
- May communicate with customers to respond to regulatory concerns/questions.
- Track regulatory department metrics.
- Implement process improvements and updates to regulatory department SOP’s.
- Assess regulatory impact on post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
- Conduct field actions.
- Minimum of a B.S. degree in a technical discipline
- 2-4 years experience in regulatory affairs within the medical device industry or life sciences
- Prior writing premarket submissions experience required
- Must have experience in FDA submissions
- CE technical file requirements experience beneficial
- Demonstrated understanding of FDA’s premarket notification requirements and Canadian medical device ! licensing procedures
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Haemonetics Corp..
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This job starts available on: Fri, 14 Jun 2013 08:02:00 GMT
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