Regulatory Affairs Specialist - Medical Device
Company: Yoh, A Day & Zimmermann Company
Location: Chestnut Hill
Posted on: February 25, 2021
Regulatory Affairs Lead (Med Device, EU MDR, Six Sigma, 510K,
FDA, International Dossiers)
The successful QA/Regulatory Lead possesses Six Sigma experience
and has managed projects where they leveraged regulatory expertise
and achieved considerable savings
Brings a wealth of experience with ISO 13485, FDA and EU Medical
Can formulated and implement overall plan to drive Quality and
Experience implementing a full Electronic Document System
Process Improvement. Can oversee and manage and identify business
needs for improving processes
Brings 5+ yrs. experience collaborating and management, balancing
Regulatory Affairs and Quality Management goals ultimately
prioritizing the overall business needs, vision and long-term
Ensures that the necessary product approvals (CE marking, 510(k)'s,
Health Canada) are obtained and maintained based on planned
Develops plans and procedures to achieve compliance to EU Medical
Communicates with regulatory agencies on behalf of the company in
relation to quality or regulatory matters.
Liaises with Notified Bodies and/or Competent Authorities/FDA
regarding regulatory and vigilance issues.
Maintains knowledge of relevant advances for the industry, US /
International standards and norms.
Provides regulatory information and risk-based assessments for the
design, service and other technical functions
Review quality related documentation for compliance with
requirements and regulatory requirements.
Supports Management Team to accomplish product cost (COG) reduction
and incremental profitability of the company without sacrificing
quality and integrity of the product.
Oversees, maintains, and creates Quality System documentation and
Participates in decision-making team relating to Medical Device
Vigilance, MDR's, product recalls and issuance of Advisory Notices,
Reviews and approves validation activities.
Bachelors in Engineering (or related) with 5+ years in Reg. Affairs
role within Medical Device industry
Minimum of 7 to 10 years Regulatory Affairs experience with
emphasis in the Medical Device industry.
Working knowledge of current FDA Quality Systems Regulation,
Canadian MDR, ISO 13485 versions, Australian regulations and the EU
Medical Device Regulations.
Other countries may become necessary.
Expertise handling product documentation and preparation of 510 (k)
/ premarket submission and International Dossiers/technical
Experience with devices containing both hardware and software
Excellent communication, interpersonal, time management, and
Appropriate certifications preferred.
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Please then call Phil at 860.405.7181
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
in the application process.PandoLogic.Category: Marketing & Biz
Dev, Keywords: Regulatory Compliance Specialist
Keywords: Yoh, A Day & Zimmermann Company, Boston , Regulatory Affairs Specialist - Medical Device, Healthcare , Chestnut Hill, Massachusetts
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