The Manager, Regulatory Affairs will be responsible for:
- Relating to premarket device licensing applications and postmarket activities including compliance activities for Luminex products (review and approval of marketing materials and complaint, recall and MDR evaluations).
- Liaison with scientific reviewers at worldwide regulatory agencies (e.g. FDA, Health Canada, EU Representative).
- Submission management activities at all stages of development and postmarket, including quality system audits, recalls and medical device reports.
Key Responsibilities & Duties:
- Responsible for compliance activities relating to MDRs (medical device reports) and product recalls, quality system audits and training as required
- Prepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU)
- Review and approve validation protocols and product labeling (including advertising materials and website) and participation in design reviews to ensure adherence to regulatory requirements
- Provide regulatory guidance to product core teams developing new products
- Manages RA Associates
- Acts as company representative with FDA, European Authorized Representative and other regulatory agencies to obtain approvals
- Interface with regulators through the submission process, through industry associations and other forums to ensure corporate awareness of critical path requirements
- Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission)
- Develop regulatory plans including rationale and internal documentation for non-filing decisions
- Other duties as assigned.
Education and Experience:
- Minimum B.Sc with at least 5 years of experience in Regulatory Affairs or a closely related discipline or
- Advanced degree in Molecular Biology or a related discipline is preferred (e.g. MSc. Candidate with 3-5 years' experience; OR PhD candidate with 2-4 years' experience)
- Experience in a GMP regulated environment, medical device industry or equivalent
- Experience working independently in a fast-paced environment with rapidly changing priorities
- Experience managing multiple projects and people who may not be your direct reports
Training, Skills and Certifications/Licenses:
- Able to interpret regulations / guidelines / standards and make appropriate judgments on what requirements are applicable to Luminex products and what source data / documents demonstrate that Luminex meets these essential requirements
- Thorough knowledge of cGMP regulations and ISO 13485 standard for quality management systems
- Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
- Ability to effectively contribute to and lead cross-functional project teams
- Strong written and oral communication skills
- Highly organized and detail –oriented with exceptional proven time management and prioritization skills
- Results and goal oriented
- Ability to work independently and with minimal supervision in a fast paced and dynamic environment
- Ability to handle the pressure of meeting tight deadlines
- Fluency in additional languages not a requirement, but considered to be an asset
Work Conditions:
- Must work onsite at Luminex office
- Travel may be required at least 10% of the time; 5% internationally
- Work situations include dealing with people; working alone; making judgements and decisions; and directing, controlling or planning the activity of others
- Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting at least 10 lbs.