Job Description
Overview:
The Manager Regulatory plays a crucial role in ensuring our products meet all necessary regulatory requirements, allowing us to bring them to market and improve patient outcomes. This position manages the RA activities of the company, ensuring that all production operations comply with the appropriate regulations.
Responsibilities:
- Manage, lead, and mentor the regulatory team.
- Develop and implement regulatory strategies for new and existing products to ensure compliance with regulatory requirements.
- Serve as the primary point of contact for all regulatory agencies, including the FDA and international regulatory bodies.
- Monitor and interpret changes in regulations and communicate potential impact to relevant teams within the company.
- Prepare and submit regulatory filings, including 510(k) submissions, PMAs, and CE mark applications.
- Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
- Conduct internal audits to ensure compliance with regulations and company policies.
- Oversee audits, inspections, and product recalls.
- Maintain all necessary regulatory documentation and ensure it is up-to-date and accurate.
- Participate in product development meetings to provide regulatory guidance and ensure compliance throughout the development process.
- Represent the company in regulatory meetings and interactions with regulatory agencies.
- Provide regulatory support for product labeling, promotional materials, and advertising.
- Train and educate company personnel on relevant regulatory requirements and updates.
- Stay informed about industry trends and changes in regulations to proactively identify potential risks or opportunities for the company.
- Collaborate with external consultants and legal counsel as needed.
- Ensure timely and accurate completion of all regulatory activities to meet product launch timelines.
- Uphold a high standard of ethical conduct and maintain strict confidentiality in all aspects of the job.
- Other duties as assigned.
Qualifications:
Education & Experience
Required:
- Bachelor’s Degree or an equivalent combination of education and work experience.
- 6+ years of medical device regulatory experience, with 2 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II medical devices.
- Previous experience leading and managing a team.
Preferred:
- Regulatory affairs certification.
Knowledge & Skills
- Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant global regulations related to medical devices.
- Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software.
- Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.
- Ability to establish credibility and build strong collaborative relationships internally and externally.
- Proven leadership and management skills, with effective interpersonal skills to influence, inspire, and engage staff.
- Possess exceptional written and verbal communication skills in preparing multi-stakeholder documents and presentations (e.g., scientific, clinical/medical, regulatory reviewer).
- Strong knowledge in medical device Design Controls and Risk Management.
- Capable of managing multiple projects and complex timelines in a team environment.
- Cross functional collaboration skills needed to foster alignment.
- Excellent influence and impact skills.
- Demonstrated leadership working through complex business needs, finding creative solutions to meet business requirements while maintaining quality and compliance.
- Strong analytical and critical thinking skills.
Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.:
$98,500 - $147,735
Additional benefits::
exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
Job Tags
Full time, Work experience placement,