Regulatory Affairs Specialist - Medical Device

Company: Yoh, A Day & Zimmermann Company
Location: Allston
Posted on: February 25, 2021

Job Description:

Regulatory Affairs Lead (Med Device, EU MDR, Six Sigma, 510K, FDA, International Dossiers)




SUMMARY

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 Device Regulations
Can formulated and implement overall plan to drive Quality and Regulatory efficiencies

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 plans





RESPONSIBILITIES:


Ensures that the necessary product approvals (CE marking, 510(k)'s, Health Canada) are obtained and maintained based on planned markets.
Develops plans and procedures to achieve compliance to EU Medical Device Regulation.
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 regulatory files.
Participates in decision-making team relating to Medical Device Vigilance, MDR's, product recalls and issuance of Advisory Notices, if required.
Reviews and approves validation activities.





REQUIREMENTS


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 files.
Experience with devices containing both hardware and software components.
Excellent communication, interpersonal, time management, and leadership skills.
Appropriate certifications preferred.





So that we are working with the most current information please email your most updated resume to philip.cooke@yoh.com. Thanks.




** REFERRALS WELCOMED! If you are not actively looking at this time, please feel free to share my contact information by forwarding this message to your colleagues who might be pursuing new opportunities




Please e-mail your resume to philip.cooke@yoh.com




Please then call Phil at 860.405.7181






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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 , Allston, Massachusetts