Regulatory Affairs Specialist- Temporary

Beschreibung

Regulatory Affairs Specialist- Temporary

Date: Start within 1 month - 15 Feb 2023

Location: Lausanne (2 days / week Home Office)

Position Summary:

• The Regulatory Affairs Specialist is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives.
• Provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions.
• Perform regulatory submission/approval activities for specific complex Diagnostic Imaging (DI) products, with focus on software and SaMD. Represent DI Regulatory with EU regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards.
• Ensure that product approvals are properly maintained, and product registration renewals are properly managed.
• Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.

Primary Duties and Responsibilities:

• Define regulatory requirements necessary for regulatory approval of products.
• Complete regulatory assessments needed to support projects and provide direction to project teams on regulatory agency expectations and guidelines to support new product development and product modifications.
• Provide direction on application of external standards to project team.
• Develop and execute EU, Notified Body product submission strategies.
• Work with the international regulatory team to develop, document, and communicate registration deliverables and strategies to the product development or project team.
• Maintain regulatory documentation in accordance with departmental practices and quality system requirements.
• Support audits and participate in CAPAs, process improvements, and other special projects as needed.
• Maintain up-to-date training with SOPs, WIs, regulations, and applicable guidance documents.

Qualifications (Knowledge, Skills & Abilities):

Minimum:

• BS degree in Science or Engineering
• Minimum of 3 years experience in Regulatory Affairs or similar field.
• Minimum of 3 years medical device or related industry experience, including EU CE Mark submissions, 510(k) submission experience and international market submissions.
• Expertise in software life cycle management, cybersecurity and data protection related to Medical Devices.
• Working knowledge and experience with quality systems regulations and guidelines, relevant ISO standards, GMP, Medical Device Regulations (MDR).
• Demonstrates planning and organizational skills.
• Demonstrates ability to coordinate and work effectively with multiple stakeholders.
• Ensures timely, clear communications to internal stakeholders on project status and issues.
• Exhibits corporate Values and Behaviors.
• Demonstrates good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
• Meets individual goals as defined in the annual objectives.
• Ability to support the business by communicating effectively, including elevating concerns to management to address issues proactively, resolve conflicts, and mitigate risks.
• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
• Strong writing skills in the form of high quality regulatory submission documents.
• Commits to driving efficiency while maintaining quality.
• Drives superior results by taking initiative, executing per project plans, and holding self-accountable to meet commitments.

Preferred:

• RAC Certification.
• Strong EU submissionexperience.
• Effective research and analytical skills.

Other:

• Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
• The work is detail oriented, often with multiple priorities.
• The environment is deadline sensitive. Frequent high-pressure situations.
• Travel requirements are minimal. Travel about 2-3 times annually for 2-3 days duration each trip.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.