Regulatory Affairs Specialist

at  LivaNova

Join us today and make a difference in people’s lives!
LivaNova is hiring a Regulatory Affairs Specialist, based in Bogotá Colombia, to join our Latin America Team. The ideal person will perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
Why LivaNova?
LivaNova is a global healthcare technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world through meaningful innovation. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .” LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.
We empower people to grow by solving challenging problems together and this is just the beginning! Join us in our mission to make an extraordinary impact on patients’ lives!

What’s in it for you?

• Great company culture: Employee Recognition Program, Service Awards, Employee Assistance Program for the employee and their family, developmental opportunities and a diverse and a flexible environment
• Excellent benefits: Health insurance, Dental insurance Life insurance and Meal Voucher
• Additional benefits for the future: Employee Stock Purchase Plan, Corporate University and Individual Development career plan
• This role will additionally have: Annual Bonus according with the company policies

Role purpose and key responsibilities
1. Lead and manage submissions, approvals, license maintenance to commercialize the Medical Devices manufactured and distributed by the Company in the International area with primary focus on CP equipment
2. Lead and manage submissions, approvals, license maintenance to commercialize the Medical Devices manufactured and distributed by the Company in the LATAM region in compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections
3. Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies
4. Coordinate with RA at manufacturing sites for the preparation and editing of the technical and formal documentation necessary to get registrations, and keep them in compliance with product changes and local regulations
5. Monitor, verify and review product documentation (Instructions for use, brochures, etc) to ensure compliance with relevant local law requirements
6. Provide regulatory expertise on relevant International laws and regulations impacting on Company products
7. Provide regulatory expertise on relevant laws and regulations of LATAM region affecting on Company products, and support the Regulatory Affairs International team accordingly

Requirements and qualifications you will need to be successful

• University degree in technical/scientific disciplines
• At least 5 years experience in the field of Sanitary Regulation, in Quality or product conformity obtained, at least in part, in Companies in the Medical Device or Pharmaceutical sectors
• Good Knowledge of the relevant laws and directives for placing on the market and commercialize the Medical Device
• Good ability and experience in collection and preparation of technical and formal documentation necessary for submissions to Competent Authorities
• Good ability in preparation of organizational procedures
• Good interpersonal skills, efficient communication, written and verbal
• Project management knowledge is a plus
• Proficient English and Spanish language. Portuguese is a plus.
• knowledge of main tools of Office Automation

Type of contract
Indefinite-term - Regular LivaNova contract
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Beware of Job Scams:
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on
https://www.livanova.com/en-us/careers
, and check that all recruitment emails come from an @livanova.com email address

Please refer the Job description for details