Healthcare Regulatory Program Manager MDSAP/ISO 13485 (f/m/d)
Location
Plattling | Germany
Job description
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Healthcare Regulatory Program Manager MDSAP/ISO 13485 (f/m/d)
Apply locations Plattling time type Full time posted on Posted 12 Days Ago job requisition id R003143
Employment Status:
Regular
Time Type:
Full time
BUILDING A WORLD CLASS TEAM STARTS WITH YOU
At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.
Job Summary:
CSA Group Europe has an immediate opportunity for a Healthcare Regulatory Program Manager MDSAP/ISO 13485 (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Healthcare Regulatory Program Manager implements and maintains procedures for high quality certification services which meet the clients’ needs in the most efficient and effective manner possible, while ensuring safe products are available in the public marketplace.
These are your duties:
- Provide oversight and review of certification applications, audit cycle plannings, and related assessments (on-site management system assessments, special audits) conducted by other deployed assessment staff (internal and external). This is in relation to customer compliance with relevant National and International Regulations and Standards.
- Ensure that assessments adequately address the regulatory responsibilities of the manufacturer regarding product safety and performance, aligning with state-of-the-art expectations.
- Formulate, maintain, and enhance assessment procedures and protocols in alignment with both CSA Group and external Authority expectations.
- Develop and deliver updated training to assessors, as well as conduct periodic calibration events for the assessment team.
- Demonstrate to relevant authorities that appropriate assessment procedures and protocols are effective, and clinical assessment projects have been conducted and reviewed according to CSA Group procedures.
- Identify, select, and evaluate internal and external technical and clinical staff.
- Represent CSA by actively participating in congresses as a speaker on technical subjects.
- Manage certification projects concurrently, ensuring compliance with all applicable safety requirements and achieving completion within specified time frames and cost deadlines.
- Provide client assistance in problem-solving without disclosing proprietary information.
- Handle a diverse range of projects, including complex ones generating high revenue levels.
- Deliver assigned projects within agreed-upon timescales consistently.
- Demonstrate the ability to accurately manage project costs within the agreed budget.
- Maintain good productivity in line with company expectations.
- Demonstrate technical competence to review the work of others per divisional quality documents.
What we expect:
- University degree in technical, medical or scientific university or polytechnic studies; or
- Engineering Technology or Associates Degree with 5 years industry related experience
- 5+ years of relevant experience in management system certification in the field of medical devices, preferably at an MDSAP Recognized AO for Medical Devices and/or IVD
- Profound knowledge of the relevant regulations, directives and guidelines for certification of MD/IVD devices under MDSAP as well as the role of the AO
- Profound knowledge of global medical device conformity assessment programs (e.g., EU MDR/IVDR, MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA)
- Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures
- Strong communication and conflict resolution skills.
- Technical competence to assess and evaluate QMSs under MDSAP.
- Ability to manage multiple assessments and changing schedules and deadlines with supervision
- Demonstrates technical competence to review the work of others per divisional quality documents
- demonstrates technical competence to perform witness auditing and mentoring per divisional quality documents
- demonstrates technical competence in 2 or more MD/IVD technical scopes
- to participate in on-site assessments as well as technical file assessments
- Excellent communication skills (verbal and written)
- Strong conflict resolution skills to be able to handle difficult situations
- Fluent in German and English, with proficiency in other European languages being advantageous .
- Ability to travel as needed (up to 15% travel)
What we offer:
- Flat hierarchies in a professional and intercultural corporate environment
- Opportunity to work from home and flexible working hours
- Attractive tasks, exciting projects and the opportunity to contribute your own ideas
- Fitness and health program for a relaxed balance to the daily work routine
- Lease a Bike
- Company pension plan
- Other Corporate Benefits
- Opportunities for constant training/learning
- Permanent employment
CSA Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion. We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws. We are an organization where opportunities are based on skills and abilities, and differences are respected and valued. Please contact us at [email protected] if you require accommodation in the interview process.
About Us
CSA Group is one of the largest standards development organizations in North America, conducting research and developing standards for a broad range of technologies and functional areas. CSA Group is also a global provider of testing, inspection and certification services for products in many market sectors, and a leader in safety and environmental certification for Canada and the U.S.
The CSA mark appears on billions of products worldwide. For more information about CSA Group, please visit .
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