Regulatory Affairs Specialist 3
Posted on: November 11, 2019
Job: Regulatory Affairs Specialist 3
Primary Function of Position:
Serve as the primary regulatory representative on Product
Engineering and Manufacturing teams. Responsibilities include
reviewing design input/output, performing regulatory assessments to
determine the impact of design/process changes, maintaining
regulatory filings and licenses and interacting with regulatory
agencies during inspections.
Roles and Responsibilities:
- Support product engineering and manufacturing teams on
regulatory issues, including review of design input, risk
management and test documentation.
- Assess the impact of the product/process changes and determine
regulatory pathway for US, EU and Canadian markets.
- Prepare and submit regulatory filings for the above markets
including 510(k) s, Non-filling justifications, Technical File
updates, Canadian License Applications
- Work with other international regulatory counterparts to
coordinate global regulatory submissions/approvals
- Provide oversight of third party agency testing (UL, EMC,
biocompatibility, sterilization assurance) as required
- Perform other duties as required
- B.S. or higher in Biomedical Engineering, Electrical
Engineering or Mechanical Engineering preferred.
- Non-technical degree with equivalent complex medical device
experience acceptable Experience:
- 8 years relevant experience working in a medical device
- 6 years of experience in regulatory submissions and technical
documentation for a medical device company
- Experience working with cross-functions teams including
engineering, manufacturing, regulatory, quality etc. Technical
- In-depth understanding of FDA, CE mark and Health Canada
- Ability to work with cross function project teams and
understand complex products
- Ability to work in a fast paced environment and handle multiple
- Strong verbal and written communication skills, proven ability
to translate technical documentation into effective regulatory
- Ability to review and provide critical feedback on design
- Able to learn internal procedures and processes and implement
the same on project teams.
- Good interpersonal skills and project management
TalentBurst is an award winning IT, Accounting & Finance staffing
firm headquartered in Boston with offices in San Francisco, Miami,
Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the
leading social media, technology, banks, utilities, pharmaceutical,
and biotech companies.We work with 75 of the Fortune 500 companies.
Our recruiting team is one of the most successful in the industry
and has a strong reputation for treating our employees well and
helping you find your next dream project.BenefitsAt TalentBurst,
one of our founding principles has been to provide our employees
with the best benefits available. Benefits we have available
include:--- Health, Dental, and Vision Plan--- 401(k) Plan--- Life
Insurance--- Immigration assistance--- Credit Union Membership---
Direct Deposit--- Vacation pay (only for FTEs)
Keywords: TalentBurst, Sunnyvale , Regulatory Affairs Specialist 3, Other , Sunnyvale, California
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