Senior Regulatory Affairs Specialist

Join us today and make a difference in people's lives!
 

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.

RESPONSIBILITY AND AUTHORITY

The primary responsibility of this position involves the preparation of regulatory submissions (510(k); IDE; IDE Supplements; PMA; PMA Supplements, CE Marking, etc.) to the FDA and the equivalent pre-market approval applications to foreign countries. Also, assistance in the implementation of the corporation’s quality goals and objectives.

Other responsibilities of this position involves assisting with compliance activities related to GMP and ISO regulations and associated standards, as well as handling corrective actions. May assist in the performance of internal quality and regulatory compliance audits.

PRIMARY ACTIVITIES

• Preparing regulatory submissions (510(k); IDE; IDE Supplements; PMA; PMA Supplements, CE Marking, etc.) for submission to the FDA and International Regulatory Agencies.

• Interfacing with the Regulatory Agencies on assigned projects.

• Responding to Regulatory Agencies requests for additional information.

• Submitting Export Clearance requests or simple export notifications to FDA per the FD&C Act, Sections 801(e) or 802.

• Interacting with the FDA and International Regulatory Agencies during quality inspections. Responsible for responding to requests for special reports during such inspections. 

• Keeping abreast of changes to the worldwide regulatory requirements and International Standard related to our products and processes.

• Formally communicating regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations.

• Reviewing QSR documentation for assigned projects to insure compliance with QSR and determining whether regulatory submissions are required.        

• Overseeing maintenance of regulatory files to ensure the Company’s compliance with regulatory requirements.

• Maintaining the Approved Products Database and Matrix.

• Supporting special research functions as requested

• Performing other duties as may be required by management

EXPERIENCE AND DESIRED SKILLS

• Experience with IDE and PMA in relation to Class III Active Medical Devices.

• Experience in Sleep Apnea Therapy or neuromodulation implantable devices.

• Familiarity with U.S. and EU regulatory requirements and submissions. 

• Skilled in the conduct of research on the Worldwide Web for regulations, guidelines, standards, medical device information, etc.

• Excellent verbal and written communication skills, analytical skills, teamwork and interpersonal skills.

• ISO 9000/QSR experience.

• Proficient knowledge of Microsoft Office, Word, Excel, and PowerPoint.

EDUCATION

Minimum of a master’s degree in biomedical engineering, science or equivalent technical discipline and at least 8 years of previous related experience in medical writing and medical device regulatory affairs.

TRAVEL REQUIREMENTS

This position may require occasional business travel of 10% or more of the time.

PHYSICAL REQUIREMENTS

Able to perform the essential duties and responsibilities of the job. This may include but is not limited to office environment work such as working at a desk with a computer, keyboard and mouse as well as receiving and sending written and verbal communication.

Employee benefits include:

• Health benefits – Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules

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