Director of Regulatory Compliance
Company: Orthofix Holdings, Inc.
Posted on: February 25, 2021
Come join our global team of dedicated professionals who through
their extraordinary efforts demonstrate every day their commitment
to our mission of improving the lives of patients. At Orthofix our
culture is built around Integrity and the core beliefs we live by:
Exceed Expectations, Work Together, Be Respectful, Get Lean and
Have Fun! As an Orthofix employee, you will become an integral part
of our culture by continually demonstrating the highest level of
integrity and our beliefs while making an impact to our vision "To
be a highly respected global orthopedic and spine company that
delivers exceptional value to our patients, customers, team
members, partners and shareholders."Director of Regulatory
Compliance How you'll make a difference? --This position is
responsible for developing, defining, educating, advocating, and
managing a superior compliance culture throughout Orthofix.
Likewise, this position must ensure QS compliance with company
quality system requirements as well as applicable standards and
regulations. The position will report to the SVP, Global
Regulatory, Quality & Clinical Affairs. This position is
responsible for ensuring Orthofix management and employees are in
compliance with the rules and regulations of regulatory agencies
and that company policies and standard operating procedures are
being followed.--What will your duties and responsibilities be?
Nothing in this job description restricts management's right to
assign or reassign duties and responsibilities to this job at any
time. Management Responsibilities:
- Ensures appropriate quality management system requirements have
been effectively established and implemented to maintain compliance
with US FDA's Quality System Regulation, the European Medical
Device Directive, ISO13485, and other relevant domestic and/or
international regulatory requirements.
- Executes Gap Analysis and/or Risk Assessments to ensure
evaluation of key areas, such as manufacturing operations,
laboratory and maintenance and engineering, are in compliance with
all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP,
- Monitors completion of Post-Market activities, including
complaint handling, to verify satisfaction of regulatory
requirements, and manages or supports Recalls and Field
- Maintains awareness of regulatory landscape and takes
appropriate steps to ensure continued QMS compliance.
- Ensures the Quality Policy and Manual have been effectively
established, communicated, and implemented to maintain compliance
with domestic and/or international regulatory requirements.
- Verifies CAPA's are implemented as required to maintain
suitability of both products and the Quality System
- May provide training and/or training presentation documentation
pertaining to FDA inspections, e.g. FDA hot topics, interaction
with FDA officials, new regulatory approaches to inspections,
- Ensures Quality Management System audits are planned,
performed, results reported to executive management, and necessary
/ required corrective and/or preventive actions are taken in
accordance with established procedures.
- Monitor risk management process, including post-production
risk, to ensure all regulatory and compliance obligations are
satisfied. What skills and experience will you need?
- 15 years experience in a medical device industry
- Bachelor's degree and 6 years related quality systems, quality
auditing, or regulatory compliance experience
- Knowledge of domestic and international medical device quality
system laws, regulations and standards, such as 21CFR Part 820, ISO
13485:2016, ISO 14971, and ISO 11135.
- Excellent technical writing skill and ability to communicate
well (both written and verbal) laterally and vertically.--
- Project planning and management capability a must
- Computer knowledge: MS Word; MS Excel, MS Project,Visio,
outlook, access, etc
- Logical cognitive skills and ability to apply scientific
methods and/or systems thinking
- Ability to identify variables affecting all aspects of
- Ability to meet deadlines and/or objectives as directed
- Must be able to interpret device law into workable, efficient
and effective practices and procedures.
- Lead auditor certification highly desired What skills and
experience would be helpful?
- Knowledge of internet investigation for new and updated
- Experience with global audits such as with Brazil and
- Current with domestic regulatory thinking
- Experience in the spine and/or orthopedic industry
- Experience with medical device reporting and complaint
management a strong plus Will you have supervisory responsibilities
in this role?
- Yes What will the physical demands and work conditions be like?
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
- Regularly required to sit for extended periods of time;
frequently required to stand, walk and use business equipment daily
such as P.C., copier, fax, telephone, etc.; occasionally required
to reach overhead, bend, and lift objects of up to 40 lbs.
- Eyesight and hearing must be correctable to standard
- Travel required 10%, therefore must be able to utilize
airplane, taxi and car.Orthofix complies with all applicable
federal, state, and local laws regarding equal employment
opportunities (EEO) to all employees and applicants for employment.
Orthofix makes its employment decisions without regard to race,
color, religion, sex, national origin, age, disability, genetic
information, or any other status protected by law. In addition to
federal law requirements, Orthofix complies with applicable state
and local laws governing nondiscrimination in employment in every
location in which the company has employees. This policy applies to
all terms and conditions of employment, including recruiting,
hiring, placement, promotion, termination, layoff, recall,
transfer, leaves of absence, compensation and training. Posted 2
Days Ago Full time OFX20258 About Us HEALING BONES. HEALING LIVES
Orthofix International began in a small farmhouse in Verona Italy
in 1980 when orthopedic researcher Giovanni De Bastiani recognized
the bone's natural repair capability, a concept he called
"dynamization" and with that in mind, he created the first external
fixation device. Today, Orthofix has grown to more than 900
employees with locations in the U.S., Italy, Germany, France, the
UK, Brazil, Australia and Puerto Rico. Our products help patients
in 70 countries around the world. Orthofix is comprised of four
strategic business units; Biostim, Biologics, Extremity Fixation
and Spine Fixation. Our products are widely distributed via the
company's sales representatives, distributors and subsidiaries. At
Orthofix we are committed to clinical research and driven by new
product introductions. We are proud of our strong partnerships with
organizations such as the Texas Scottish Rite Hospital for Children
in Dallas and the Musculoskeletal Transplant Foundation. We take
pride in developing superior products and providing world class
education for surgeons and field-based Orthofix personnel
supporting them around the world. Orthofix makes a difference in
the lives of our patients by providing our surgeon customers with
innovative medical devices to meet the needs of their patients.
Every day we are optimizing our operations, improving efficiencies
and examining our systems to provide the best support possible to
our representatives, surgeons and patients.
Keywords: Orthofix Holdings, Inc., Lewisville , Director of Regulatory Compliance, Executive , Lewisville, Texas
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