Manager, Regulatory Affairs - Urology
About The Position
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
Requirements
- Bachelor's degree, preferably in a scientific, technical, or project management discipline
- Minimum of 7 years' experience in Regulatory Affairs or a related field within the medical device industry
- Demonstrated success in managing regulatory submissions, including FDA and Notified Body experience
- Demonstrated success serving as the Regulatory Affairs lead on large cross-functional development teams
- Experience supporting manufacturing or operations-driven projects and achieving global change approvals
- Submission experience for single-use, implantable, and medical electrical equipment products (e.g., FDA, PMDA, CFDA, ANVISA, Health Canada, TGA)
- Deep understanding of the product development process and design control
- Strong technical understanding of regulatory procedures and relevant medical terminology
- Ability to manage multiple projects independently
- Excellent written and oral communication, technical writing, and editing skills
- Ability to work independently with minimal supervision
- Strategic thinking and ability to influence product direction
Responsibilities
- Lead a team in achieving organizational goals.
- Guide, coach, direct, and develop direct reports; promote these practices across the organization.
- Foster a diverse, inclusive environment that enables all team members to contribute fully.
- Ensure compliance with company policies and applicable regulations.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
