Leadership at a growing Specialty Medical Device company has tasked Junto HLS with recruiting a Regulatory Affairs Director to lead global market expansion and the clearance of new product lines working directly with the Vice President of RA/QA.
Reporting Structure: Reporting to the Vice President of RA/QA
Support the VP of RA/QA in developing and implementing regulatory strategies. Act as a Management Representative. Implement quality system regulatory procedures and initiatives in to achieve compliance with ISO 13485:2003. Coordinate and lead internal and external audit Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements, and business process improvement initiatives. Responsible for creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Class I and II products.
- Act as Management Representative for the company as required.
- Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), Technical Files, Canadian Device License Applications, and internal “Letters to File”.
- Support Regulatory submissions and on-going regulatory compliance for product development process.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product and manufacturing changes for compliance with applicable regulations.
- Review and approve regulatory submissions and approvals, including design and manufacturing changes and labeling.
- Review and approve test protocols to support regulatory submissions.
- Provide technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
- Develop and implement departmental and divisional policies and procedures.
- Supervise 1 to 2 direct reports
- Other duties as assigned
- Bachelor of Science in Mechanical Engineering; prefer masters degree.
- Knowledge of FDA medical device regulations, guidance, and import/exports requirements.
- Knowledge of European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
- Knowledge with medical device labeling and promotional requirements.
- Strong understanding of the quality system and regulatory affairs functions.
- Thorough knowledge of product development process, design control and Quality Systems.
- Strong technical knowledge of medical device (Class I & Class II) products.
- Minimum 5 years of Regulatory Affairs medical industry experience.
- 1 to 2 years supervisory experience preferred
- Experience in 510(k) submission process.
- Proficient in timely review of technical and clinical data.
- Proficient in FDA and international regulations (EU and Canada)
- Excellent managerial and organizational skills and abilities.
- Strong leadership and motivational skills with effective team building capabilities.
- Technical knowledge of medical devices.
- Good presentation skills.
- Excellent computer skills and proficiency with MS Office products
- Strong written and oral communications skills; strong technical writing skills.
- Detail oriented and self-motivated.
- Ability to write clear, concise, and well thought out technical documents.
- Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills
- Ability to work under minimal supervision and independently.
- Must be able to work in a timeline-driven environment.
- Santa Rosa, CA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.