Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 25,000 employees. The company is listed on Euronext Amsterdam. More information can be found at www.dsm.com.
Are you accustomed to working cross-functionally with a variety of internal departments to ensure regulatory compliance of medical devices and biomaterials? We are looking for proven professional to manage the diversity of activities with DSM Biomedical and these fast developments require the ability to manage multiple projects and adapt quickly to change. Does this sound like you? We are seeking a Regulatory Affairs Specialist to join our growing team in Exton, PA.
As the Regulatory Affairs Specialist, you will provide regulatory guidance and support to product development projects including development of global regulatory strategies and preparation and management of global regulatory submissions.
Material master file portfolio – ensure (a) files are submitted to regulatory agencies as needed to support COE business activities; and (b) periodic updates are completed in a timely manner.
Prepare domestic/international submissions for new products and product changes as required to ensure timely approval for clinical studies and market release [510(k), IDE, PMA, Investigator Brochure, Design Dossier, Master File, etc.].
Lead implementation of Regulatory Affairs policies, programs, and procedures.
Implement strategies for domestic and international governmental approval to introduce new medical devices and biomaterials to global market.
Represent Regulatory Affairs on PMP teams and provide support on regulatory requirements as needed.
Review significant regulatory issues with manager, as necessary, and negotiate submission issues directly with agency personnel as required.
Provide on-going support to Clinical, Marketing, Manufacturing, Product Development and Quality teams for regulatory issues and questions and to ensure continuous regulatory compliance of clinical and commercial medical devices and biomaterials.
Responsible for FDA Medical Device Listing of our products as well as our OEM products.
Provide product and test requirements to Product Development in order to support domestic/international submissions.
Prepare project status reports for management review as requested and to meet regulatory requirements as needed.
Prepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary.
Support clinical trial activities, including monitoring, as needed.
Bachelor’s degree required (degree in life-science a plus). Prior applicable work experience may be substituted for degree requirements.
Minimum of 3 years prior experience in regulatory affairs with extensive experience with FDA and other regulatory submissions.
Regulatory Affairs Certification (RAC) desired.
Knowledge of U.S., European and Canadian regulations.
Experience with medical devices desired; animal tissue and/or orthopedics preferred.
Experience interacting with regulatory agency staff through email, telephone and face-to-face dialogue.
Working for DSM means the opportunity to really contribute to improve people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance.
Procedure & Contact
Interested in this position? Please apply on-line by sending us your CV via the career portal (www.dsm.com/careers). Reference check procedures are part of the DSM Recruitment & Selection Process. You will be contacted when these references checks are required.
DSM Biomedical is a market leader in regenerative medicine and in the supply of biomaterials to the medical industry. We have established a team of exceptionally talented and experienced individuals who are committed to innovation, collaboration and improving the medical professional and patient experiences. Our company possesses expertise in the research, development, scale-up and supply of novel materials and medical devices. This is a growing market and is characterized by long term commitment. Intellectual property is of paramount importance in this high value-added market arena. DSM Biomedical is part of the DSM Innovation Center and provides a proprietary product portfolio and a wide range of biomedical materials that enable the replacement, repair, enhancement and the regeneration of tissue and organ functions in the body. Its novel materials-based solutions are designed to meet the needs of the medical device and pharmaceutical industries. The ultimate objective is to improve the outcome for patients. DSM’s medical device expertise spans one of the broadest portfolios of medical materials, and technologies, including biostable polyurethanes, ultra-high molecular weight polyethylene’s, resorbable polymers, ceramics, collagens, extracellular matrices, silicone hydrogels, device coatings, and drug delivery platforms. Millions of products are produced each year for applications in orthopedics, sports medicine, ophthalmology, general surgery and cardiology.
Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.
DSM Biomedical develops novel materials-based solutions to meet the present and future needs of the medical device industry. The company’s product portfolio includes coatings, drug delivery platforms, mechanical devices, and a wide range of biomedical materials that enable the replacement, repair, enhancement and the regeneration of tissue and organ functions in the body. Its novel materials-based... solutions are designed to meet the needs of the medical device industry.
The biomedical market is highly innovative and dynamic. As a partner to industry leading medical device companies, DSM Biomedical must be pro-active in understanding the needs of the customer and end-user (physician, patient) within the biomedical context.
For continued growth and sustainability, new products are continually developed while the existing business base is maintained. The Director of US Operations at the DSM Biomedical Exton Site has oversight for three primary areas (biomaterials production, device manufacturing and materials). These areas produce both lower-level and intermediate products as well as perform intermediate and final packaging to ready the product in its final configuration for shipment to the customer. As such, effective supply chain planning and timely production is critical to meeting delivery requirements and must be accomplished in a manner that emphasizes safety, quality, service and cost; balanced with a commitment to employee motivation and development.