Sr.Regulatory Affairs Specialist

#ChangeMakers

Ready to make an impact?

We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

#WeChangeDentistry every day. Be part of it.

Salary: $85,000.00 - $90,000.00/Annually. The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.

Summary Of Position

The employee will partner with Clinical Affairs, R&D, and Marketing teams to conduct analysis that will support generating clinical evidence for existing products, new product development, and sustaining activities related to product quality and continuous improvement. The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy, conducting regulatory research, producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area. This position reports to the Director, Clinical & Regulatory Affairs.

Essential Functions And Duties

This position is responsible for, but not limited to, the following:

• Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Participates in advocacy activities of a technical and/or tactical nature.
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Assists other departments in the development of SOPs to ensure regulatory compliance.
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
• Provides regulatory information and guidance for proposed product claims/labeling.
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
• Supports and assists in global regulatory submissions.
• Coordinates responses to regulatory agencies as part of the submission and approval process.
• Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
• Reviews labeling and promotional materials for compliance with applicable regulations and policies.
• Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
• Provides department support during internal and external audits.
• Develops and maintains procedures and/or work instructions for product registrations.
• Maintains regulatory listings and registration.
• Follow written SOPs and record accurate technical data in various forms. Summarize and present information in written form such as memos, test reports, or presentation slides.
  
  

Non-essential Functions And Duties

• Perform other related duties and responsibilities as assigned
  
  

Physical Attributes

• Observe and hear warning signs and signals within all areas of the company
• May type on a computer, using a computer mouse and computer monitor for up to 8 hours at a time
• Will be working in a fast-paced, team environment
  
  

Work Environment

• Work is performed in an office environment
• The employee may occasionally be exposed to dust
• The noise level in the work environment is usually quiet to moderate
• Will work in a fast-paced, team environment
  
  

Minimum Qualifications

• B.S. or B.A. in Science or Engineering (Biology, Materials Science, Chemical/Biomedical Engineering, Polymer Science
• 4 years of experience in Regulatory Affairs, other work within the medical device industry, or other work in a regulated industry
  
  

Preferred Qualifications

• Demonstrated project management skills
• Ability to be self-directed and self-motivated
• Proficient in data analysis and presentation in written and graphical form
• Good written and verbal communications skills
• Demonstrated collaborative skills
• Research, statistics and data skills relevant to drawing reliable conclusions from experimental data
• Experience in a regulated industry such as Dental, Medical, or Pharmaceuticals
  
  

Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.

• Very Competitive total compensation plans
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!
  
  

Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.

Videos To Watch

https://youtu.be/3lq5BLAvIdQ

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: United States : Fremont (CA) || United States : San Francisco (CA)

Travel Percentage: 0 - 10%

Requisition ID: 16392

16392