The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities along with supporting all other geographical regions registrations. In addition, this position will help support RA management with guidance and mentoring of department employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).
Prepare and support 510(k), IDE, PMA and Design Dossier submissions as required.
Prepare technical files for CE marking activities and notified body interaction as required.
Provide regulatory support and guidance for post market activities including remedial actions, labeling and advertising and promotional material.
Write and revise departmental processes and procedures as required.
May have direct supervisor responsibilities; provides direction to support personnel.
Must have knowledge of the U.S. and European medical device regulations
Must have excellent written and verbal communication skills
Must be self-motivated and have the ability to take ownership of her/his responsibilities independently
Must be able to prioritize and handle several projects concurrently
Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
Must be able to provide leadership and mentoring skills to less experienced regulatory personnel
Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
EDUCATION and/or EXPERIENCE:
BS in a scientific discipline with 5-7 years employment in the medical device industry in areas of product registration, compliance or quality systems
Regulatory Affairs Certification (RAC) desired.
Internal Number: R-368165
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.
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.