Orthofix
Position Title
Senior Regulatory Affairs Specialist Location:
Carlsbad | Lewisville Position Type:
Full time Req ID:
OFX25341
Description Why Orthofix?
Guided by our organizational values Take Ownership | Innovate Boldly | Win Together we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further.
How you\'ll make a difference Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained.
Responsibilities
Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports.
Prepare Technical Files.
Prepare and review product labeling.
Prepare correction and removal (recall) reports and coordinate recall related activities.
Provide regulatory affairs support to project teams.
Develop regulatory strategies for new products.
Review design changes and assess regulatory implications relative to the design change.
Provide regulatory support for quality system related changes (ECOs, MCOs, NCMRs, SDRs, etc.).
Help drive process and compliance improvements activities.
Lead health hazard evaluations to determine risk associated with post-market product issues.
Provide regulatory affairs support during external inspections (FDA, BSI, etc.).
Provide regulatory affairs guidance to other Orthofix departments, as necessary.
Regular attendance required.
Qualifications
College degree or equivalent work experience in Regulatory, Quality or R&D.
Minimum of 5 years experience in Regulatory Affairs.
Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements.
Excellent oral and written communication skills.
Public speaking proficiency.
Willing to mentor others.
Ability to prioritize, conduct team meetings, and meet project deadlines.
Nonessential Skills, Experience and Qualifications (preferred)
Science or technical degree.
RAC Certification.
Experience with ISO 14971.
Supervisory Responsibilities
N/A.
Physical Demands and Work Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as PC, copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects up to 20 lbs.
Eyesight and hearing must be correctable to standard level.
Travel required 10-15%.
The anticipated salary for this position for an employee located in California is $97,000 to $128,500 per year, plus bonus, based on performance, and benefits. Final pay offered will depend on factors including experience, education, and location. This pay scale may not reflect pay scales for employees in other states or locations.
Disclaimer The duties listed above are representative of the essential functions of this position. The job description does not constitute an employment contract and is subject to change at the sole discretion of the employer. This document does not alter an employee's at-will status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex, gender identity, sexual orientation, national origin, ancestry, citizenship status, veteran status, marital status, pregnancy, age, disability, or other protected status in accordance with federal, state, and local laws. This policy extends to all aspects of employment practices.
About Us Since 1980, Orthofix has evolved to be a leading medical device company with a spine and orthopedics focus. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.
Our medical device company is headquartered in Lewisville, Texas, with primary offices in Carlsbad, CA, and Verona, Italy. Our global footprint includes additional facilities in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.
Orthofix is recognized as one of the leading orthopedic medical device companies in the world. We are committed to improving patients\' lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet patient needs daily.
PI277790322
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Senior Regulatory Affairs Specialist Location:
Carlsbad | Lewisville Position Type:
Full time Req ID:
OFX25341
Description Why Orthofix?
Guided by our organizational values Take Ownership | Innovate Boldly | Win Together we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further.
How you\'ll make a difference Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained.
Responsibilities
Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports.
Prepare Technical Files.
Prepare and review product labeling.
Prepare correction and removal (recall) reports and coordinate recall related activities.
Provide regulatory affairs support to project teams.
Develop regulatory strategies for new products.
Review design changes and assess regulatory implications relative to the design change.
Provide regulatory support for quality system related changes (ECOs, MCOs, NCMRs, SDRs, etc.).
Help drive process and compliance improvements activities.
Lead health hazard evaluations to determine risk associated with post-market product issues.
Provide regulatory affairs support during external inspections (FDA, BSI, etc.).
Provide regulatory affairs guidance to other Orthofix departments, as necessary.
Regular attendance required.
Qualifications
College degree or equivalent work experience in Regulatory, Quality or R&D.
Minimum of 5 years experience in Regulatory Affairs.
Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements.
Excellent oral and written communication skills.
Public speaking proficiency.
Willing to mentor others.
Ability to prioritize, conduct team meetings, and meet project deadlines.
Nonessential Skills, Experience and Qualifications (preferred)
Science or technical degree.
RAC Certification.
Experience with ISO 14971.
Supervisory Responsibilities
N/A.
Physical Demands and Work Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as PC, copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects up to 20 lbs.
Eyesight and hearing must be correctable to standard level.
Travel required 10-15%.
The anticipated salary for this position for an employee located in California is $97,000 to $128,500 per year, plus bonus, based on performance, and benefits. Final pay offered will depend on factors including experience, education, and location. This pay scale may not reflect pay scales for employees in other states or locations.
Disclaimer The duties listed above are representative of the essential functions of this position. The job description does not constitute an employment contract and is subject to change at the sole discretion of the employer. This document does not alter an employee's at-will status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex, gender identity, sexual orientation, national origin, ancestry, citizenship status, veteran status, marital status, pregnancy, age, disability, or other protected status in accordance with federal, state, and local laws. This policy extends to all aspects of employment practices.
About Us Since 1980, Orthofix has evolved to be a leading medical device company with a spine and orthopedics focus. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.
Our medical device company is headquartered in Lewisville, Texas, with primary offices in Carlsbad, CA, and Verona, Italy. Our global footprint includes additional facilities in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.
Orthofix is recognized as one of the leading orthopedic medical device companies in the world. We are committed to improving patients\' lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet patient needs daily.
PI277790322
#J-18808-Ljbffr