- Lead product focused team of Regulatory Specialist/Associate(s), utilizing strong technical regulatory skills in developing strategies for complex projects and issues.
- Assist in the mentoring and development of Regulatory Affairs Specialist/Associate(s) including providing input during the interviewing, hiring, training, and evaluation of direct reports..
- Participate on multidisciplinary product development teams and communicate regulatory requirements effectively.
- Provide regulatory input to product lifecycle planning, risk assessments, manufacturing changes, and labeling reviews.
- Conduct appropriate research to develop strong regulatory strategies for new products.
- Determine issues which may create regulatory obstacles and investigate solutions to address these issues.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Provide regulatory support to external Notified Body audits and FDA inspections as necessary.
- Oversee the organization and preparation of regulatory submissions and all applicable documentation.
- Adhere to Code of Ethics for Regulatory professionals.
- Assist in regulatory due diligence processes.
- Provide input on departmental SOP development and implementation.
- Ensure regulatory files are maintained as required by departmental procedure.
- Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
- Comply with Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Note: 0% of this job involves direct R&D activities
EDUCATION / EXPERIENCE REQUIREMENTS:
- Bachelor's degreerequired, (scientific or law discipline preferred).
- 5+ years of relevant experience is required.
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
- Ability to plan, mentor, and perform regulatory and quality work in the medical device industry with strong analytical and critical thinking skills.
- Strong project management skills, written and oral communication skills, and an in depth and working knowledge of FDA and EU regulatory history, guidelines, policies, and standards.
- Proficient in MS Word, Excel, Power Point, and Outlook required.
- RAC certification is a plus.
10% if located in Massachusetts, 50% if located in Minneapolis
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery.
We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.