Regulatory Affairs Intelligence Project Manager

Chi siamo

ENOVIS™

Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo. Per ulteriori informazioni su Enovis, visitare il sito www.enovis.com.

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

Di cosa ti occuperai | What You'll Do

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together.

As a key member, employees will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Regulatory Affairs Intelligence Project Manager

Reports To:

VP RA, Recon and/or Dir/ Sr. Dir. RA

Location:

San Daniele del Friuli (UD) - Italy

Business Unit(s) Description:

Recon Corporate

Job Title/High Level Position Summary:
This Regulatory Affairs (RA) Intelligence Project Manager is responsible for developing, facilitating and overseeing the process for managing standards and regulations impacting Recon business units (BUs). This role will establish and maintain a process by which the business remains compliant to external influences (medical device standards and regulations) through pro-active monitoring and critical assessments, orchestrate subject matter experts (SME) to determine, document and implement necessary changes to the QMS/processes/practices within impacted BUs. This role must communicate changes in regulatory/standards environments affecting the development, approval, and lifecycle management of Enovis Recon medical devices.

Essential Duties and Responsibilities:

• Primarily responsible for the establishment and maintenance of a process which will ensure Recon BUs remain in steady compliance to external influences. This process must comprehensively evaluate the impact of Regulations and Standards developments on Enovis’s current and future medical devices (pipeline and established marketed products).

• Monitor, react and interpret global regulatory developments, guidance documents, and policy changes from agencies such as FDA, EU MDR, TGA, Health Canada, ANVISA and other international regulators. 

• Convene relevant SMEs to analyze the impact of regulation and standards & make interpretations of how best to comply to both statutory requirements as well as consensus Standards developments (such as ISO, EN or standards issued by ANSI, ASTM, ASME, etc.)

• Collaborate with SMEs to document gap analyses and implement required changes with the QMS to ensure Enovis current and future medical device products remain compliant to state-of-the-art requirements.  

• Broaden awareness of external impacts to the global business.

• Analyze and synthesize the Regulatory Intelligence for reporting during periodic business reviews. 

• Provide strategic regulatory guidance during all phases of product development, submission planning, and post-marketing phases.

Education & Experience

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s degree required (preferred: Master’s degree in relevant field: ie mechanical or biomedical engineering, engineering and/or natural sciences, health, law). 

• Certifications such as Regulatory Affairs Certification (RAC) – Preferred not required.

• Minimum 6 years of relevant regulatory / medical device experience

• Solid understanding of regulated industries, preferably medical devices w/ experience in orthopedics, arthroplasty and SaMD / navigation design considerations

• Experience with maintaining Quality System compliance for medical solutions development and medical device / systems manufacturing

• Demonstrated ability to interpret changes, work collaboratively, assess impact, expertly guide the development of and maintain compliance to procedure / process for managing regulations and standards.

• Experience with global Health Authorities, including but not limited to: US FDA,  EU MDR, Australia (TGA & PLAC mandatory)

• Self driven, player & coach, capable of managing without authority and organizing dynamic cross-functional teams

• Healthy communication and interpersonal skills

• Ability to manage complex initiatives and deliver to task

• Occasional yet routine work collaboration with US & EU time-zones required.

Working Conditions:

• Working conditions are an office setting; with occasional laboratory and manufacturing facility visits.  Occasional travel may be required.

Dichiarazione di pari opportunità

Enovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.

EOE AA M/F/VET/Disability Statement

At Enovis, we are committed to providing equal employment opportunities to all individuals. Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person’s qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment.