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LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. 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 are hiring a Senior Regulatory and Clinical Specialist to join our team. This position will lead clinical evaluation activities, review promotional materials and create regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The selected candidate will also function as a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.
General Responsibilities:
Author, prepare and update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirements.
Conduct systematic literature searches, appraisal, analysis, and summarization of data for state-of-the-art, safety and performance periodically.
Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members.
Responsible for regulatory authority queries on clinical evaluation.
Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulation as the Regulatory representative.
Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents.
Maintain clinical evaluation & PMS procedures i.e., SOPs/WIs, and Templates.
Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.).
Direct interface with the FDA and International Regulatory Agencies on assigned projects.
Lead improvements to labeling in collaborate with the cross functional team.
Perform regulatory assessments of changes as part of the change management process.
Skills and Experience:
6 years of previous related experience in medical writing and medical device regulatory affairs.
Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
Demonstrated experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, technical files).
Medical writing experience with US and EU regulatory requirements understanding in medical device.
Demonstrated negotiation and conflict resolution skills.
Demonstrates ability to rapidly learn new therapeutic areas.
Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.
Education:
Additional Information:
Target compensation range: 100,000 to 110,000 plus annual bonus. Pay rate will be offered based on experience.
Location: Remote.
Occasional travel may be required.
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.
