Medical Device Regulatory Affairs Specialist
About the position This role is for a reputed company/Principal/Senior Regulatory Affairs Specialist in the med-tech space, playing a key role in driving reputed company's success and competitiveness in the healthcare and life sciences sector. The specialist will collaborate with product engineering and development teams on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical 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 units but will also interact with other reputed company business units selling to the health and life sciences industries. The position requires an individual who can reputed company up with the fast-paced environment of software development and an evolving regulatory landscape, acting as a collaborative, creative problem solver dedicated to excellence. The position is reputed company at the principal 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, Cloud-native 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 units and interact with other reputed company business units selling to the health and life sciences industries.
Requirements
- 10+ years of experience (for Principal level; Senior and reputed company levels will also be considered).
- Ability to reputed company up with the fast-paced environment of software development and an evolving regulatory landscape.
- Regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence.
reputed company-to-haves
- BA/BS or advanced degree preferred.
- Experience with SaMD in areas such as Regulatory Affairs, Quality 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 quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations.
- Understands continual improvement and risk management.
- Excellent written and verbal communication skills.
- Ability to adjust and adapt to changing priorities in a dynamic environment.
- Ability to reputed company in a fast-paced and continually evolving business environment.
Benefits
- Flexible medical, life insurance, and retirement options.
- Volunteer programs.
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