Job Description Summary

Reporting to the Sr. Director of Regulatory Affairs, the RA Associate Director for Process Excellence and Continuous Improvement (CI) is responsible for leading the RA team members involved in all regulatory processes and continuous improvement activities.
In this role, you will oversee all regulatory processes, ensuring the appropriate level of compliance, as well as simplification and value for the business. You will work closely with other RA teams to deploy and harmonize practices and processes.
You will lead the team responsible for maintaining RA processes and fostering a culture of continuous improvement, ensuring both compliance and value for PS customers and the business. This position works closely with R&D and Quality Engineering to simplify processes cross-functionally.

Job Description

About the role

Reporting to the Sr. Director of Regulatory Affairs, the RA Associate Director for Process Excellence and Continuous Improvement (CI) is responsible for leading the RA team members involved in all regulatory processes and continuous improvement activities.

In this role, you will oversee all regulatory processes, ensuring the appropriate level of compliance, as well as simplification and value for the business. You will work closely with other RA teams to deploy and harmonize practices and processes.

You will lead the team responsible for maintaining RA processes and fostering a culture of continuous improvement, ensuring both compliance and value for PS customers and the business. This position works closely with R&D and Quality Engineering to simplify processes cross-functionally.

Your main responsibilities will include:

• 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 the regulatory processes (amongst others DEO and change control) to ensure the appropriate level of compliance. 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 promotional material process 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 R&D within the pharmaceutical and medical device industries, ideally with expertise in drug-device combination products.

The successful candidate will be both an inspirational leader and cross functional contributor, with experience in regulatory functions, strong knowledge in design control and regulation, and a proven track record in submission dossier preparation and interactions with regulatory authorities.

The candidate needs also to show experience and tangible results in change management and new process implementation.

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.

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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.

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Required Skills

Optional Skills

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Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional 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 Annual