Manager Quality, Regulatory Affairs
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing. Our primary capabilities include: Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
Confluent Medical Technologies is growing! We’re looking for a Manager, Regulatory Affairs to join our Fremont, CA Team
As a uniquely qualified candidate, you will:
Regulatory affairs manager is responsible for ensuring that their organization is adhering to applicable regulations. Regulatory affairs manager helps develop strategies to ensure regulation compliance. They also make sure that necessary documentation is completed and submitted. Regulatory Affairs Manager provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. They communicate regulatory information to multiple departments and ensure that information is interpreted correctly
Responsibilities and main tasks:
• Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
• Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
• Maintain current knowledge of relevant regulations, including proposed and final rules
• Manage activities such as audits, regulatory agency inspections, or product recalls
• Participate in the development or implementation of clinical trial protocols
• Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
• Provide expert regulatory input to in-licensing evaluations and due diligence activities
• Provide advice about regulations to manufacturers/NPD
• Coordinate successful submissions and approval of all applications
· Ensure all technical files, risk management plans and reports, clinical evaluations are up-to-date, risk management, post market surveillance and post market clinical follow-up are in compliance with current standards
· Monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
· Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met
· Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
· Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil local, FDA and European regulatory and quality standards
• Plan, undertake and oversee product trials and regulatory inspections
• Keep up-to-date with changes in regulatory legislation and guidelines
• Write comprehensible, user-friendly, clear product information leaflets and labels
• Liaise and negotiate with regulatory authorities
• Develop and establish policies and standards that convey the best practices in the company
• Review and report overall quality status to the management team
• Project management of development of new generic products
· Train staff in regulatory policies or procedures
- Hands on and knowledge of MDD/MDR
- Strong knowledge and understanding of UDI and FDA porta
- Advise others on legal or regulatory compliance matters
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
- Strong initiation and organizational skills
- Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
- Strong analytical skill and technical/ scientific competence
- Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options and situations
EDUCATION and/or EXPERIENCE: BS in a related field of study; and minimum of 10 years of related experience and/or training; or equivalent combination of education and experience. A Master’s degree in an applicable field of study would be an asset. Regulatory Affairs Certification is preferred
OTHER SKILLS and ABILITIES: Ability to use PC’s and associated software. Ability to effectively deal with and negotiate with representatives of various government and auditing agencies. Good written and oral English communication skills.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all‑inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.
We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.
Confluent Medical Technologies is an equal opportunity employer.
Learn more here
Job posted: 2020-12-31