Senior Regulatory Affairs Specialist

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. 

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

Objectives:

Responsible for providing Regulatory Affairs support under direct supervision supporting regulatory authorizations to market medical device products in global markets. This position requires the incumbent to work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for various country submissions. May provide preliminary review of product technical information, certification documentation, master file documents. Position may support facility inspections and participate in other regulatory support activities as required.

The position acts as a liaison between product development teams and global regulatory agencies to communicate technical product design for product approvals through participation in preparation of product submissions and license renewals, and daily maintenance of business issues.

Responsibilities:

• US submissions and support of Non-US product submissions (new registrations, renewals, technical files) based on input from RA Managers and Regional Regulatory groups.
• Research engineering standards and medical device regulations.
• Support RA Managers in interactions with FDA and international government agencies with product approval issues.
• Support/participate in Regulatory projects.
• Participate as required in audits of B&L facilities.
• Conduct FOI requests.
• Support Sales, Customer Service groups and customers by providing regulatory documentation required for bids and customs issues and product material/sterilization requests.
• Assist in providing applicable regulatory information to support import/export applications.
• Ensure records related to product approvals and licenses are accurate and maintained according to departmental requirements.
• Administrative functions as needed
• Other job responsibilities as needed

Requirements:

• BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law or related regulatory affairs experience with medical devices or pharmaceuticals
• Minimum 2 years' experience in Regulatory Affairs for Medical Devices with familiarity in preparing submissions for US Class II/Class III medical devices and/or EU class Ila/Class Ilb medical devices. Knowledge of medical device or drug GMP's.
• Knowledge of U.S. FDA medical device regulations and guidance documents.

Preferred Qualifications:

• Experience preparing non-US medical device registrations.
• Must have excellent communication, organization, time management and writing skills.
• Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, and professionalism.
• Strong questioning and problem-solving skills.
• Must be self-motivated by working independently and having the ability to take ownership of his/her responsibilities.
• Must have command of English language.
• Computer literate with general office software and internet use.
• Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures.
• Ability to write routine reports and business correspondence.

We offer competitive salary & excellent benefits including: 

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date 

• 401K Plan with company match and ongoing company contribution 

• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time 

• Employee Stock Purchase Plan with company match 

• Employee Incentive Bonus 

• Tuition Reimbursement (select degrees) 

• Ongoing performance feedback and annual compensation review 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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