Quality and Regulatory Manager

Sterling-Hoffman Executive Search Located in: Oregon
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JOB DESCRIPTION

Our client, a leading medical device company, is currently seeking an ambitious Quality and Regulatory Manager to join their team. This is a unique opportunity for a highly motivated individual with a go-getter attitude and a drive to succeed.

1) Act as a subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to see product globally
2) Create and oversee the quality management system
3) Ensure best and most current practices are leveraged company-wide
4) Collaborate internally and externally to determine customer requirements and ensure that they are met
5) Partner with critical suppliers to maintain the highest rate of supplier performance and compliance
6) Establish use of metrics to monitor the suitability and effectiveness of the quality management system
7) Serve as the management representative
8) Manage regulatory affairs in support of medical device design & development, and manufacturing, including clinical, preclinical, and marketing issues (US and ROW)
9) Support planning, preparation, and submission of US FDA registrations, including 51 European registrations, CE marking, design/technical dossiers and maintain documentation
10) Advise personnel and project teams on quality systems and regulatory requirements
11) Coordinate and present regulatory information, and negotiate with and influence management and colleagues to ensure requirements are met
12) Provide strategic regulatory insight regarding product development plans
13) Manage interactions with EU Authorized Representative, Notified Body, FDA, and other regulatory contacts
14) Maintain awareness of global regulatory legislation and assess its impact on business and product development programs, registrations, and gear action towards compliance
15) Review and approve product labeling and MARCOM
16) Provide regulatory assessment, input and approve product design and development projects
17) Provide regulatory reviews and approve engineering change orders
18) Schedule and facilitate regulatory compliance audits
19) Manage the complaint process and adverse events reporting to national requirements
20) Ensure that company and quality systems are compliant with all federal, state, local and company specific regulations as they apply to medical device facility
21) Ensure that internal and supplier audits are performed per current regulatory guidelines/procedures
22) Coordinate with external consulting resources as needed
23) Manage CAPA process and work with process owners to ensure appropriate corrective actions plans are implemented and verified for effectiveness
24) Develop and deliver regulatory training
25) Provide oversight into the ongoing maintenance of quality system procedures
26) Ensure that changes to the procedures are consistent with the intended structure of the quality system

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the medical device industry is strongly preferred
    4) Preference will be given to candidates with recent experience in quality and regulatory management

    For the right individual, this role is a fantastic opportunity to be a key player in the exceptional success of this renowned company. If you are qualified and think this could be you, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:


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