Sr. Regulatory Affairs Specialist (IRC2973) at Plainsboro

Job Description

The Sr. Regulatory Affairs Specialist is responsible to participate on manufacturing transfer projects as a Regulatory representative.  This position works in partnership with operations, manufacturing, Quality Systems, Engineering and Product Development to facilitate overall regulatory compliance for transfer of manufacturing processes and/or products from one facility to another and manufacturing facility projects.  These activities  include the development, implementation, and monitoring of RA compliance and submissions information to be in accordance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485:2003, the Canadian Medical Device Regulations (CMDR), the Medical Device Directive (93/42/EEC), TGA, PAL and other applicable regulatory agencies. 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.

 

  Proficient use of Microsoft Office, Word, Excel, PowerPoint, Visio

  Must be project oriented requiring minimal supervision

  Must possess excellent communication skills both written and oral

  Regulatory Affairs experience

  Project Management Skills

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with an appropriate level of independence for this position. 

 

More specifically, the Sr. Regulatory Affairs Specialist:

 

  Provides Regulatory Affairs guidance and strategy for transfer project planning and review; advise site personnel (Engineering and Operations) on the development of new equipment and/or processes and registration requirements with FDA and International markets.

  Manages US and International Integra Regulatory processes for strategic planning and registration documentation for registration and approvals associated with production transfers.

  Identifies and communicates potential risks associated with strategy scenarios.

  Assists with and/or prepares 510(k) Premarket Notifications, Regulatory Assessment Decision Trees, PMA Supplements, Change Notifications for Design Dossiers as required.

  Reviews and approves validation protocols and reports for regulatory impact.

  Review changes in manufacturing facility processes, procedures, and testing methods and evaluate for regulatory impact.

  Provides regulatory review and approval of Engineering Change Orders, nonconformance reports, and validations for the products as needed.

  Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

  Identifies appropriate standards for manufacturing site; communicates and evaluates potential impact.

  Participates in periodic training sessions on Regulatory-related training topics.

 

Job Requirements

  Bachelors degree with 5+ years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for device and/or drug, biologic products. Masters degree with 3 years experience preferred.

  Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs), Investigational New Drug (IND), or 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 and other International Regulation regulatory requirements.

  Must have strong writing, project management and communication skills.

Country: USA, State: New Jersey, City: Plainsboro, Company: Integra Life Sciences.