What are the responsibilities and job description for the Regulatory Specialist position at Actalent?
Description:
JOB SUMMARY:
The Regulatory Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the local organization on regulatory topics. They are also the primary liaison to marketing and sales groups with regards to regulatory requirements for marketing communications and other customer-facing communications
JOB DUTIES:
- Design change engineering change order (ECO) reviewer as regulatory representative
- Train teammates on regulatory considerations as an ECO owner or ECO reviewer
- Prepare FDA submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance
- Lead and provide guidance to work teams composed of engineering and marketing personnel with regards to regulatory planning and execution. This includes standards testing strategy, labeling specifications, etc.
- Assist with product hazard analyses and recall assessments. Coordinate and lead field corrective action (FCA) and recall strategy as needed
- Support design verification and validation including usability and risk management study planning and report generation
- Maintain regulatory affairs product files to support compliance with requirements and standards
- Maintain the company's medical device listing and device establishment registration
- Interpret, execute and recommend modification to internal guidelines, work instructions, procedures.
- Participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release. This would include FDA subchapter J on radiological device requirements (Buffalo Grove facility)
- In collaboration with regulatory management, lead submission activities for devices in gaining required clearance through the processes of IDE's, 510(k), PMA's, CE marking. This includes submissions for product lines manufactured for other facilities
- Lead regulatory gap analysis projects and action implement for topics such as but not limited to risk management, cybersecurity, biocompatibility, and restricted materials safety
- Lead UDI submissions
Skills:
Medical Device, Med Device, 510K, cybersecurity, cyber security, regulatory, ECO, engineering change order, wifi, bluetooth, FDA, product registration, eStar, ISO 14971, ISO 13485, IEC 60601, IEC 62304, IEC 62366, MDSAP
Additional Skills & Qualifications:
MUSTS:
- At least 3 separate 510K submissions (3 different projects) from start to completion
- Cybersecurity experience
- Medical device experience
PLUS:
- eStar experience (new application form the FDA requires)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Responsibilities:
Description:JOB SUMMARY:The Regulatory Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the local organization on regulatory topics. They are also the primary liaison to marketing and sales groups with regards to regulatory requirements for marketing communications and other customer-facing communicationsJOB DUTIES: - Design change engineering change order (ECO) reviewer as regulatory representative - Train teammates on regulatory considerations as an ECO owner or ECO reviewer - Prepare FDA submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance - Lead and provide guidance to work teams composed of engineering and marketing personnel with regards to regulatory planning and execution. This includes standards testing strategy, labeling specifications, etc. - Assist with product hazard analyses and recall assessments. Coordinate and lead field corrective action (FCA) and recall strategy as needed - Support design verification and validation including usability and risk management study planning and report generation - Maintain regulatory affairs product files to support compliance with requirements and standards - Maintain the company's medical device listing and device establishment registration - Interpret, execute and recommend modification to internal guidelines, work instructions, procedures. - Participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release. This includes submissions for product lines manufactured for other facilities - Lead regulatory gap analysis projects and action implement for topics such as but not limited to risk management, cybersecurity, biocompatibility, and restricted materials safety - Lead UDI submissionsSkills:Medical Device, Med Device, 510K, cybersecurity, cyber security, regulatory, ECO, engineering change order, wifi, bluetooth, FDA, product registration, eStar, ISO 14971, ISO 13485, IEC 60601, IEC 62304, IEC 62366, MDSAPAdditional Skills & Qualifications:MUSTS: - At least 3 separate 510K submissions (3 different projects) from start to completion - Cybersecurity experience - Medical device experiencePLUS: - eStar experience (new application form the FDA requires) .Salary : $40 - $70
