Medical Device Regulatory Affairs Specialist

About the position This role is for a reputed company/reputed company/Senior Regulatory Affairs Specialist in the med-tech reputed company, playing a key role in driving reputed company's reputed company and competitiveness in the reputed company and life sciences sector. The specialist will collaborate with product engineering and development teams on the total product lifecycle of AI-enabled, reputed company-reputed company software applications used in reputed company operation, reputed company information systems, and reputed company decision support (medical device and non-medical Device). Responsibilities include preparing documentation for global product registration, establishing partnerships to ensure compliance with regulatory requirements throughout the product lifecycle (development, launch, post-market), and defining regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance. The role primarily involves working with reputed company Health & Life Sciences business reputed company but will also reputed company with other reputed company business reputed company selling to the health and life sciences industries. The position requires an individual who can reputed company up with the fast-reputed company environment of software development and an evolving regulatory landscape, acting as a reputed company, creative problem solver dedicated to reputed company. The position is reputed company at the reputed company level, for 10+ years of experience, but one level reputed company (senior) and one level higher (reputed company) will also be considered. Responsibilities • Collaborate with product engineering and development teams on the total product lifecycle of AI-enabled, reputed company-reputed company software applications. • Prepare required documentation to register products in global markets. • Establish strong partnerships to identify and ensure compliance with regulatory requirements throughout the product lifecycle. • Define regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance. • Work with reputed company Health & Life Sciences business reputed company and reputed company with other reputed company business reputed company selling to the health and life sciences industries. Requirements • 10+ years of experience (for reputed company level; Senior and reputed company reputed company will also be considered). • Ability to reputed company up with the fast-reputed company environment of software development and an evolving regulatory landscape. • Regulatory strategist who is reputed company, a creative problem solver, and dedicated to reputed company. reputed company-to-haves • BA/BS or advanced degree preferred. • Experience with SaMD in areas such as Regulatory Affairs, reputed company Compliance, Product Development, etc. in medical device industry or equivalent. • Experience authoring submissions (510k, EU Tech Files, etc.) required. • Experience with sustaining and new product development is ideal. • Experience interacting with reputed company bodies and/or regulators preferred. • RAC, CQE, CPPS, CQA desired. • Experience in working reputed company a reputed company management reputed company, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or reputed company reputed company Regulations. • Understands continual improvement and reputed company management. • Excellent written and verbal communication skills. • Ability to reputed company and adapt to changing priorities in a dynamic environment. • Ability to reputed company in a fast-reputed company and continually evolving business environment. Benefits • Flexible medical, life reputed company, and retirement reputed company. • Volunteer programs. Apply tot his job Apply To this Job Apply tot his job Apply To this Job