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Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocare Medical. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining our quality system.
Key Responsibilities- Support product development and complete global regulatory submissions in connection with the marketing of products.
- Maintain knowledge and understanding of applicable regulations and harmonized standards.
- Participate in internal and external audits and inspections, including follow-up activities, as required.
- Provide regulatory guidance and inputs to departments or development project teams regarding design and development, change control, testing, labeling, and marketing of products.
- Perform and maintain registration and product listing/licensing with regulatory agencies, and renewal of pertinent business licenses, as required.
- Review and approve product labeling such as product labels, data sheets, user manuals, safety data sheets, and promotional materials.
- Participate in conducting company-wide compliance training, as needed.
- Generate Technical Documentation, where required, including but not limited to preparing regulatory plans, clinical evaluations, and post-market reports.
- Provide regulatory support and participate in CAPAs as needed.
- Keep up to date with changes in regulatory legislations that may impact the company and perform gap analysis, as necessary.
- Develop and review SOPs as needed to ensure regulatory compliance.
- Complete and support regulatory submissions (e.g. 510(k) etc.) and product registration in accordance with established regulatory strategies and plans.
- BS/BA Degree with five (5) years working in pharmaceutical or medical device industry or MS Degree with 3 years of relevant experience.
- Strong oral and written communication skills.
- Willing to set and drive aggressive project timelines.
- Capable of strategic thinking and proposing solutions to regulatory problems.
- Attention to detail and good organizational skills.
- Problem solving and investigative skills.
- High level of reading comprehension.
- Demonstrates independent judgment within broadly defined policies and ability to lead multiple projects.
- Strong computer and internet research literacy.
- Knowledge of FDA/EMEA, ISO/GMP.
- Company Sponsored Health Insurance - medical, dental, vision.
- Company Sponsored Life Insurance.
- Voluntary Benefits.
- Retirement plan - 401(k).
- PTO.
- Paid Holidays.
BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.
