Remote - Regulatory Affairs Specialist - Transfer Project - Med Device
This is a 1-year contract role with benefits.
Roles and Responsibilities:
- Provide regulatory input to ensure product compliance in target markets.
- Develop regulatory strategies and submission pathways considering country-specific requirements, product claims, and submission sequencing.
- Collaborate with cross-functional teams to prepare and submit regulatory documents such as MDR EU Technical Files or submissions to global regulatory bodies (e.g., NMPA, TGA).
- Assess product changes to determine the need for new or revised licenses or registrations.
- Develop and manage plans for timely renewal submissions to ensure uninterrupted product supply.
- Review and approve advertising and promotional materials for regulatory compliance and approved claims.
- Contribute to the writing and editing of technical documentation.
- Research and compile background information for regulatory submissions from diverse sources.
- Ensure adherence to pre- and post-market approval requirements.
- Support regulatory inspections and audits as needed.
Required Qualifications:
- Bachelor's degree in Science, Engineering, Regulatory, Legal, or a Life Science-related field from an accredited institution.
- Minimum of 2 years of experience in a regulated industry, preferably in Regulatory Affairs, or in related areas such as Quality Assurance, Design, or Engineering.
- Proficiency in English with strong verbal and written communication skills.
- Experience using Microsoft Office applications (Word, Excel, PowerPoint, Teams, etc.).
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
- Experience in medical device regulatory affairs.
- Strong problem-solving and project management abilities.
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We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Pay range is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Talascend also offers a variety of benefits including: health and disability insurance, 401(k), EAP, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, plan requirements, schedule type, and client work site mandates.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.