Senior Regulatory Affairs Specialist

Duties and Responsibilities

• Identify, interpret and apply global regulations applicable to STEMCELL’s products and processes 

• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies 

• Build processes, policies and practices to support regulatory compliance for medical devices

• Lead project teams as the compliance representative to assess requirements, and develop and execute plans to support corporate initiatives 

• Lead in preparation and review of regulatory documentation and submissions to regulatory bodies including but not limited to Technical Files, Master Files, Site registrations, 510(k)s and risk analysis impact determinations to products 

• Conduct documentation review and approval to meet importation/exportation requirements for raw materials and finished products 

• In collaboration with Supply Chain, ensure timely resolution to compliance issues relating to the global transport of STEMCELL products 

• Create and lead training initiatives specific to quality and regulatory 

• Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies. 

• Prepare, review and implement procedures and processes across the organization 

• Identify and evaluate and fill gaps related to compliance that cause risk to the business and regulatory certifications

• Provide leadership and guidance to all staff as related to quality and regulatory practices 

Qualifications

• Education:  Master’s or Bachelor’s Degree or Technical Diploma in relevant field.

• Experience: 7-10 years’ experience in Regulatory Affairs and/or Quality Assurance in the biotech industry or equivalent.

• Specialized knowledge:  Knowledge of country specific regulatory requirements (e.g., cGMP 820s, ISO 13485 / 9001, FDA, Health Canada, European IVD device regulations, etc.) is a requirement. Experience with preparation of regulatory documentation such as a MF, IND, DHF, CMC is an asset. Strong knowledge in Design Control is a requirement.

• Skills:  Proven ability to coordinate and execute responsibilities relating to Regulatory Affairs.  Excellent technical and scientific report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes. Excellent communication skills. 

• Abilities:  Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis. Exercises judgment within undefined practices and procedures that may be incomplete or complex.  

• Other characteristics such as personal characteristics:  Comfortable making presentations before groups; ability to question and not always be satisfied with the status quo; capability to balance compliance with business; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.