JR-021951 Regulatory Affairs Specialist- Remote work option
Location: Mountain Lakes, New Jersey
Type: Full Time
Required Education: 4 Year Degree
US Regulatory Affairs
Internal Number: JR-021951
EUROIMMUN US, a subsidiary of PerkinElmer, is an MDSAP registered, ISO 13485:2016, 21 CFR 820 compliant medical device company that develops, manufactures, distributes, and performs service and installation activities of in vitro diagnostic test kits, instruments and software used in the detection of autoimmune status, allergies, infectious diseases and antigen detection.
As we continue to grow, we are seeking a Regulatory Affairs Specialist to support our national Regulatory Affairs department as well as our Central Regulatory Affairs team in our headquarters in Germany. The Regulatory Affairs Specialist supports the planning and execution of regulatory activities for the registration of the assigned product portfolio. This position is actively supporting the product teams to make the products and related documentation compliant to the national and international requirements. The Regulatory Affairs Specialist serves as a subject matter expert for creation of regulatory reports and regulatory requirements. He/she will drive results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals.
The work can be office based or remote and is based on collaboration with our headquarters in Germany and our national subsidiary in the US.
You actively support all pre-market and post-market regulatory activities of the assigned product portfolio
You keep track of the national and international requirements for product registrations
You work with the product teams to ensure the products and related documentation are compliant with the regulatory requirements
You support with national US registration and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746.
You create registration dossiers used for registration at international authorities.
You are a team player who works proactively to achieve our joint goals
You collaborate cross-functionally and lead regulatory efforts to comply with new regulations (e.g. IVDR) and other requirements including changes to international standards.
You hold a university degree (e.g. Engineering, Natural Sciences, IT, etc.) with further education in Regulatory Affairs
You are experienced in Regulatory Submissions and Project Support
Your proficiency in English and preferably also in German helps you to create the documents for international authorities and communicate effectively with your colleagues
Knowledge in MS Office tools required
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Bachelor of Science in a life sciences discipline.
Minimum of 2 years regulatory work experience in a medical device or pharmaceutical company
Master's degree and further education in Regulatory Affairs preferred.
Experience with in vitro diagnostic device.
Experience in FDA 510k, PMA and BLA submissions & CE declarations.
Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs.
Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, manage and support multiple projects and resources in a fast paced and changing environment.
Maintain knowledge of the medical, biological and technical / analytical aspects relevant to the products.
Demonstrated and effective interpersonal, communication and negotiation skills
Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates.
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.