Regulatory Affairs Specialist

What You'll Do

• / Duties Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions Participate in negotiations and interactions with regulatory authorities during the development and review process Support international product registrations as needed Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities Review promotional and advertising material Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements Participate in internal and external audits as needed Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements Ensure compliance with design controls in accordance with ISO 13485 standard and 21 CFR 820 regulation.
• Manage Internal Audit program in accordance with ISO 13485 and MDSAP and host all 3rd party audits including FDA.
• Provide training of QMS processes Perform other duties as assigned or required Previous Experience/Skills Needed & Education Requirements MS Regulatory Affairs Experience with ISO 13485, MDSAP and FDA QSR Should be willing to learn & shouldn’t be afraid of getting their hands dirty! #LI-CC1 For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S.
• Department of Commerce - Bureau of Industry and Security and/or the U.S.
• Department of State - Directorate of Defense Trade Controls.
• As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
• We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
• Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days