Regulatory Affairs Manager

We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel.

As a Regulatory Affairs Manager, you will be responsible for:

- Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers)
- Lead and mentor a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.
- Manage the development of US and International regulatory strategies and verification and validation activities for assigned product submissions.
- Author submissions (510k, MDR files, MDD changes) independently. Ensure timeliness of regulatory submissions according to business needs.
- Actively lead and/or manage the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies.
- Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.
- Develop regulatory strategies and internal processes around ad/promo reviews based on regulations; Provide expert guidance to teams and oversee review of promotional and advertising material for adherence to approved product claims and regulatory compliance.
- Manage RA leads as well as manage partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations.
- Manage rollouts of product changes with corporate and international regulatory teams.
- Manage the planning and coordination of rollouts of product changes with corporate and international regulatory teams.
- Provide oversight and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971.
- Manage the regulatory review of complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
- Manage and establish labelling requirements per regulations and review labelling that requires regulatory review and approval to ensure compliance with government regulations
- Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization.

Your profile:

- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- ** Minimum of 4 years in Regulatory Affairs working in an FDA regulated industry in the Medical Devices**:

- Strong experience in working effectively with cross-functional teams and provide regulatory input
- **Experience working with FDA locally and nationally.**:

- ** Expert applied knowledge of domestic and/or international medical device regulations including 510k and international dossier submissions**:

- Strong applied understanding of business strategies and tactics, including an understanding of regulatory impact.
- Proven experience in effectively communicating and working with US FDA, European Notified Bodies, Competent Authorities, and other regulatory agencies.
- ** Proven skills in the planning, management, and approval of CE registrations and US 510(k)**:

- Must have strong data analysis, technical writing, project management and communication skills.
- Demonstrated skills handling multiple demanding projects and in contributing to multiple projects simultaneously.
- Develops proposals for solutions and applies solutions to identified issues.
- Develops plans to meet pre-defined Regulatory goals.
- Willingness to take ownership and accept responsibility for actions and decisions.

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