Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

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 SeaSpine and 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!

How you'll make a difference?

The Regulatory Affairs Program Manager is responsible for managing U.S. and global regulatory pre-market submissions and other pre-market filings to acquire and maintain appropriate commercial distribution clearances for specific product families / technologies.The Regulatory Affairs Program Manager is a key partner to the Research & Development and Marketing teams in achieving new product development and commercialization.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Prepare and maintain domestic product submissions including FDA 510(k), PMAs, and PMA annual reports

• Prepare and maintain global product submissions including international registrations and license applications

• Prepare and maintain Technical Documentation to support product CE-marking

• Develop regulatory strategies for new products.

• Provide regulatory affairs support to project design teams

• Review and approve product labeling

• Review design and/or process changes and assess regulatory implication relative to the change

• Provide regulatory support for product and quality system related changes

• Provide regulatory affairs support during FDA inspectionsand Notified Body audits

• Provide regulatory affairs guidance to other Orthofix departments, as necessary

• Provide support for the company's transition from EU MDD to EU MDR

• Help drive process and compliance improvements activities

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor's degree (science or technical preferred)

Experience, Skills, Knowledge and/or Abilities:

• 10+ years of experience in Regulatory Affairs, specifically in the medical device industry

• Experience with implantable orthopedic devices.

• Demonstrated knowledge of FDA QSR, ISO 13485, EU MDD, EU MDR, CMDR and global submission requirements

• Strong attention to detail and the ability to multitask

• Excellent oral and written communication skills

• Ability to prioritize, conduct team meetings, and meet project deadlines

• Public speaking proficiency

• Willing to mentor others

• Travel up to 25% domestic and international

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• N/A

Additional Experience, Skills, Knowledge and/or Abilities:

• Regulatory Affairs Certification (RAC)

• Experience with electrical medical devices and associated IEC standards

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• No additional physical requirements or essential functions for this position.

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.