Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist

Location: San Jose, CA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift: Work hours: 8AM – 5PM

Client: Medical Device Company

Job Category: Regulatory Affairs / Compliance

Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

PMO notes -

• How many interview rounds? Phone or video? 2 - One phone and one video.
• How soon are you looking for someone to start? by June 30, 2021
• Is the role strictly temp or is there a possibility to convert to perm?
As I understand there is no budget for a permanent position
• Is this position remote or local? Local preferred

• What are the top three tangible must have skills you are looking for?
1) Detail oriented, with emphasis on accuracy and completeness.
2) Effective written and oral communication skills
3) Effective analytical/problem solving skills

• Anything additional you would like to share about the position -
Experience:
1) A minimum of a Bachelor's of Science degree
2) A minimum of 2 years’ experience working in a medical device environment.
3) A minimum of 2 years prior experience working on product regulatory submissions.

Job Description: Regulatory Affairs, Temporary

RESPONSIBILITIES

Responsible for the preparation and documentation of ROW (Rest of World) regulatory submissions to government agencies. Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments.

1. Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic and RUO reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents.

2. Acts as a liaison for international RA team by tracking requests for information and monitoring international laws/ regulation. Provides product performance data as requested by international personnel and other corporate groups.

3. Track global registration status for project teams and new products. Log, track, and prepare reports.

4. Provides RIM and ACR support as needed

5. Brings Regulatory Affairs questions/issues to the attention of RA management.

6. Performs other related duties and assignments as required.

7. Perform surveys as needed with RoW RA partners and provide summary to key stakeholders.

MINIMUM QUALIFICATIONS ·

A minimum of a Bachelor's of Science degree · A minimum of 2 years’ experience working in a medical device environment. · A minimum of 2 years prior experience working on product regulatory submissions.

KNOWLEDGE AND SKILLS ·

The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology. · Regulatory Certification is a plus. ·

Previous experience working for a medical device manufacturer. · Knowledge of regulations related to product lasers is a plus. ·

Experience with flow cytometry, hematology, and/or immunoassay are a plus. Orientation for detail work product, with emphasis on accuracy and completeness. ·

Effective written and oral communication skills. ·

Good organizational and planning skills; drives for results. ·

Effective analytical/problem solving skills. ·

Good interpersonal skills that involve working well in a team environment and the ability to lead others. ·

Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. ·

Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. ·

Working knowledge of project management and design control. ·

Ability to identify areas of concern in moderately complex projects and manage change. ·

Computer literacy (PC, Microsoft Word/Excel/PowerPoint)