Syner-G BioPharma Group is an organization with roots to the Greater Boston area started by industry leaders in 2007 who saw a niche in the pharmaceutical consulting space and leveraged their subject matter expertise and industry knowledge to grow an organization through hard work, trusted relationships, a collaborative approach, and delivering best-in-class client services, growing the company and geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery.
We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous paid time off program, 13 paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; Boulder, CO; and Chennai, India.
The Director, Medical Device works closely with our clients to offer technical expertise in the design, development, and testing of medical devices as well as regulatory compliance strategies. Within this role, the Senior Consultant will conduct comprehensive risk assessments and prepare and review technical aspects of regulatory submissions.
The Director, Medical Device position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel is required for this position (Up to 20%).
(This list is not exhaustive and may be supplemented and changed as necessary.)
- Offer technical expertise in the design, development, and testing of medical devices, ensuring they meet regulatory requirements and industry standards. Collaborate with engineering teams to facilitate the successful development of innovative and safe medical devices.
- Conduct comprehensive risk assessments, including hazard analysis and risk mitigation strategies, to ensure the safety and efficacy of medical devices. Provide guidance on risk management processes and documentation.
- Stay up to date with evolving FDA, EU, and international regulations and guidelines pertaining to medical devices, combination devices, and related technologies. Provide expert guidance to clients on regulatory compliance strategies to enable regulatory approvals.
- Small Molecule Expertise:
- Proficiency in small molecule drug/device delivery systems and associated technologies.
- Knowledge of pharmaceutical chemistry and formulation science for small molecule drugs.
- Understanding of analytical techniques for small molecule drug characterization.
- Biologics Expertise:
- Familiarity with biologics drug/device delivery systems, including injectables and biodegradable implants.
- Understanding of bioprocessing and biomanufacturing principles.
- Knowledge of analytical techniques specific to biologics, such as mass spectrometry and protein characterization.
- Collaborate closely with clients to understand their specific needs and challenges, providing tailored solutions and recommendations. Serve as a trusted advisor, offering insights on market access, and product development.
- Develop and deliver training programs and workshops on medical device regulations, quality assurance, and compliance topics to empower clients and internal teams.
- Prepare and review technical aspects of regulatory submissions, including 510(k) submissions, CE Mark applications, and other regulatory documentation as needed, ensuring accuracy and completeness.
- Domestic and international travel is required for this position. (Up to 20%)
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.
A bachelor’s or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required.
- 15 plus years of relevant experience in global device/combination product pharmaceutical product development leading to successful submission of IND/NDA/BLA.
- Minimum of 5 years of experience as an active member of design review meetings.
- Extensive knowledge of Design Controls and FDA QSR 21 CFR 820.
- Knowledge of EU Medical Device Regulation.
- Extensive knowledge of ISO 13485 (QMS for MD), ISO 10993 (Biocompatibility testing), ISO 14971(Risk Management for MD).
- Demonstrated experience of complying with medical device/combination drug regulations, including GCP, ICH guidelines, and other industry-specific regulations.
- Familiarity of international testing standards for various classes/types of devices.
- Demonstrated experience with risk management principles as part of medical device/combination product development and throughout product LCM.
- Worked in an R&D, Technical and/or Quality role supporting medical device projects from early development throughout LCM.
- Proven track record of successful medical device development, and quality management system implementation.
- Adept at applying risk-based and phase-appropriate quality approaches.
- Project management experience is a plus.
Knowledge, Skills, and Abilities:
- Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.
- Ability to work independently with minimal supervision and problem solve proactively.
- Skilled communicator, both written and verbal, who can present ideas and critical information to clients and internal team members effectively.
- Strong organizational skills and attention to detail.
- Outstanding professional demeanor and discretion.
- Customer service mindset.
- Ability to work effectively within a team environment, strong collaborator and interpersonal skills.
- Demonstrated leadership and management skills.
- Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER
Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.