Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Are you passionate about regulatory affairs and customer excellence? Join us as the Associate Director for Sustaining Engineering Activities and Customer Excellence! You'll lead a dynamic team in managing regulatory activities for market products and providing top-notch customer support globally. Oversee tasks like dossier maintenance, change management, and geographical expansion, ensuring compliance and exceptional service. Collaborate with RA teams, R&D, and Quality Engineering to streamline operations and drive continuous improvement. We seek a leader with experience in regulatory affairs and customer-facing roles within the pharmaceutical and medical device industries, ideally with expertise in drug-device combination products. The successful candidate will be an inspirational and servant leader with a proven track record in submission dossier preparation and interactions with regulatory authorities. If you have a degree in Life Sciences or a technical discipline, strong project management, negotiation, and communication skills, and comprehensive knowledge of U.S. medical device regulations, apply now and take your career to the next level!Job Description
Main responsibilities will include:
- Built and lead the team ensuring the right balance between support and empowerment as well as the right level of development and coaching to support cultural change and position RA team as solution providers.
- Own all the regulatory activities across platform for the products already on the market to ensure the appropriate level of compliance and customer support. You will be responsible for identifying valuable trends and insights that will benefit the current business and support the long-term goals of the PS strategy.
- Own all the customer excellence activities and responsible to ensure the appropriate customer support across the direct product and regions as well as extract the value for the business.
- Own promotional material review activities and business specific procedures if relevant. Accountable for alignment of PS external communication & claims to regulatory requirements.
- Educate/Train the PS cross-functional teams on EU and FDA requirements applicable both to pharmaceutical systems and our customers, on an ongoing basis, to ensure current and future associates understand the regulatory framework and environment.
- Accountable for the appropriate registrations with the Competent Authorities as well as regular updates when required. Develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if necessary.
About you:
For this role, we are seeking a leader with experience in regulatory affairs and customer facing (business orientation) within the pharmaceutical and medical device industries, ideally with expertise in drug-device combination products.
The successful candidate will be both an inspirational and servant leader, with experience in regulatory functions and management, strong knowledge in regulation dossier maintenance, regulation and pharmaceutical environment, and a proven track record in submission dossier preparation and interactions with regulatory authorities (Medical device and pharmaceutical environment). The candidate will show also an appetence for continuous improvement and change management.
Also you will have:
- Pharmacist or Scientist or University degree in Life Sciences. B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry). Advanced degree preferred; medical training preferred.
- Ability to navigate in a matrix environment and participate to build the solid foundations so that RA is a business partner in all needed aspects and has a strong and respected voice.
- Demonstrated project management, negotiation, and communication (written and oral) skills.
- Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit: https://bd.com/careers
--We are the makers of possible--
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
--Why join us?--
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become amaker of possible with us!
Required Skills
Optional Skills
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Primary Work Location
FRA Le Pont-de-Claix CedexAdditional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
91 800,00 € - 165 200,00 € EUR AnnualSuccess Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.