Regulatory Affairs & Quality Assurance Director

  • Contract
  • Anywhere

Website CAD Engineering Resources, Inc.

CAD Engineering Resources, Inc.

Company : CAD Engineering Resources, Inc.

Country: United States

Location : Brighton, Michigan

Post: Wed, 01 Feb 2023 20:46:11 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Regulatory Affairs (RA) and Quality Assurance (QA) Director – Brighton, MI.
Long-term contract position – potential Direct Placement
*The ideal candidate for this role will have FDA-QMS System experience along with being familiar with HIPPA and chemicals.

The Regulatory Affairs (RA) and Quality Assurance (QA) director will implement the overall regulatory strategy and quality management system (QMS) at our client to ensure submissions to the FDA in compliance with regulations and guidelines for medical devices comprised of both hardware and software components.

Responsibilities of the Regulatory Affairs and Quality Assurance Director:
Lead, coordinate, author, and review regulatory filing documents
Prepares FDA submissions, including 510(k) submissions, Device Master files, technical files, and post launch surveillance for product changes and/or new products as required to ensure timely clearance or approvals
Reviews clinical study documentation
Collects documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies
Creates and maintains regulatory submission timelines and tracks deliverables to ensure company goals are met
Develop overall organizational regulatory and strategies
Provides strategic input and regulatory advice to project teams on development programs including new product development and changes to existing products
Conduct regulatory research and analysis
Keeps abreast of current regulatory landscape for medical device
Develops and communicates recommendations regarding new/emerging regulations to management and project teams
Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks
Interact with regulatory authorities
Represents the company and works directly with regulatory authorities on regulatory issues and submissions
Leads the preparation of responses to questions from regulatory authorities
Facilitates the preparation of responses to question from regulatory authorities to support regulatory filings
Provide in-house training in quality/regulatory guidelines as applicable to team members
Manages and modifies a complete and comprehensive quality system to support development of Class I, II, and III medical device products
Reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities
Conducts internal audits of various products and processes and host regulatory agency audits as needed
Evaluates, authors, and reviews SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and system are well-controlled and comply with applicable regulations
Develops plans and lead validation of electronic systems for quality and compliance to FDA 21 CFR Part 11

Qualifications of the Regulatory Affairs and Quality Assurance Director:
Regulatory and Quality experience
BS Degree or higher along with 5-8 years or related work experience in Regulatory and/or Quality for medical devices and software
Demonstrated understanding of laws, regulations, standards, and guidance and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
Experience in working with quality aspects of medical device and GMP in general, including implementation of FDA guidance on Cybersecurity Management and Software contained in Medical Device
Proven ability to successfully interact with regulatory authorities and manage major submissions and critical projects to meet deadlines
Proven track record and experience with regulatory submissions with a thorough understanding of FDA regulations

Preferred Qualifications of Regulatory Affairs (RA) and Quality Assurance (QA) Director:
Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be a plus
RAC certification will be a plus
Experience in medical software development areas is desirable but not required
Implementation of Regulatory/Quality along with medical device product development and manufacturing experience will be preferred

Soft Skills needed of Regulatory Affairs (RA) and Quality Assurance (QA) Director:
Ability to manage and prioritize multiple tasks while keeping with submission timelines
Self-motivated, well-organized, detail oriented, and has excellent written and verbal communication skills
Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
Strong leadership skills and experience, a team player, a fully engaged, hands-on professional capable of working collaboratively and independently
Computer technical skills
Experience in electronic submission building tools, document formatting, and publishing standards
Experience using electronic document management systems (EMDS)


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