Senior Regulatory Affairs Specialist - Lewisville

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 sh ...

Job 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.

What will be your Duties and Responsibilities? 

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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 implication relative to the design change.

• Provide regulatory support for quality system related changes i.e. 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.

What skills you'll need?

• 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 (not necessary but 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 P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.

• Eyesight and hearing must be correctable to standard level.

• Travel required 10- 15%, therefore must be able to utilize airplane, taxi, car etc.
  
  The anticipated salary for this position for an employee who is located in California is $97,000 to $128,500 per year, plus bonus, based on performance, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.  The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer.  Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.